Information Technology Jobs in Wheaton, MD
418 positions found — Page 25
U.S. Army General Surgeons lead the way of a world-class military health care team.
If you are a Surgeon and want to combine your passion for patient care with a desire to serve in the U.S. Army, a career as an Army General Surgeon might be the one for you.
Outstanding Opportunities
As a General Surgeon on the U.S. Army health care team, you’ll be at the front line of medical and surgical innovations and a wide range of procedures. The surgical advancements being developed by the U.S. Army Medical Department assist patient outcomes and changing the medical practice, from groundbreaking work in regenerative medicine to the development of 3-D anatomical models to assist with surgical pre- and post-op planning. You will examine, diagnose, consult, and prescribe courses of treatment, and perform surgeries for Soldiers, retirees and their family members. You will also participate in continued education programs, additional trainings, seminars and conference to learn, grow and collaborate with fellow general surgeons for the benefit of your patients and the Army as a whole.
If you choose to serve in the Army Reserve, you will be able to serve your country as needed while still supporting your community.
Regardless of how you serve, a career as an Army General Surgeon allows you to serve the Army in critical ways.
Outstanding Benefits
When you join the Army Medical Corps, you’ll be making a difference in the lives of our Soldiers and the country at large while gaining access to invaluable opportunities, like supporting humanitarian missions, leadership training, and state-of-the-art equipment, all while earning a competitive benefits package.
Benefits may include:
Repayment of qualified education loans to lending institution, paid annually over a maximum of three years while serving
Based on your field of concentration, you may be eligible for an accession bonus, paid over a four-year period while serving. You may also be eligible for special pay as a physician
For Army Reserve, a monthly stipend through the Specialized Training Assistance Program (STRAP) for physicians currently enrolled in an accredited residency program
Travel opportunities within the Unites States and internationally
Up to 30 days of paid vacation earned annually
Enrollment into the Uniformed Services Blended Retirement System
No- to low-cost medical and dental care for you and your family
Commissary and post exchange shopping privileges
For Active Duty, you may qualify for a monthly stipend through the Financial Assistance Program (FAP) while enrolled in an accredited residency program.
Specialized training to become a leader in medicine
Eligibility Requirements
Must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited U.S. school of medicine or osteopathy
Foreign graduates may apply if they have a permanent certificate from the Educational Council of Foreign Medical Graduates
Must have a current license to practice medicine in the United States, District of Columbia or Puerto Rico
Must be eligible for board certification
Must have completed at least one year of an approved Graduate Medical Education (GME) internship
Must have completed a training program in general surgery
Must be a U.S. citizen to serve on Active Duty
Must have a permanent U.S. residency for Army Reserve
Have questions or want more information?
To find out more information about general surgery in the U.S. Army, visit . You may also reach out to your local Army Medical Recruiter to learn how you can get started on your journey as an Army General Surgeon.
Position Summary
The George Washington University Medical Faculty Associates, an independent, non-profit academic clinical practice group affiliated with The George Washington University (GW), is seeking a full-time cardiologist in the Department of Medicine’s Division of Cardiology. Responsibilities include providing excellent patient care to heart failure cardiology patients in the outpatient department
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
- Provide excellent patient care to hospitalized patients and consultations for outpatients
- Teach residents and medical students
- Maintain an active research program
**The pay for this role will be $287,000- $400,000**
Basic Qualifications: Applicants must be board-eligible/board certified in Advanced Heart Failure and Transplantation and licensed in the District of Columbia by the time of appointment. Applicants should have demonstrated skills in the area of Advanced Heart Failure and Mechanical Circulatory Assist Devices, including complex heart failure management; pre and post VAD management, including other temporary mechanical circulatory support devices; and cardiac intensive care management. Right heart catheterization and endomyocardial biopsy skills are preferable.
About GW MFA
MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals.
The GW MFA’s leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
This medical center facility serves over 117 beds serving children, adolescents, adults and older adults.
This position requires administrative and clinical oversight for inpatient facilities and outpatient clinics.
Responsibility for 8 employed psychiatrists, several NPs, as well as independent contracts.
Qualified candidates will possess:? Degree of Doctor of Medicine ? Board Certification from the American Board of Psychiatry and Neurology.? Previous leadership experience or medical director experience preferred.
? Excellent interpersonal relationship skills? Excellent skills in maintaining highly confidential information ? Skilled in compiling clinical documentation in a timely manner? Experience working with an electronic medical record preferredFinancial package and benefits:? Competitive salary and bonus ? Medical, dental, vision, life, AD&D, disability insurances, flexible spending accts.? PTO, funds and designated time off for continuing medical education? Retirement savings plan with matching? Professional fees toward license, DEA, journals, societies
General Summary of Position
Collaborates and consults with physicians nurses and other healthcare professionals to ensure safe efficacious and cost-effective prescribing dispensing administration and monitoring of medication in the provision of pharmaceutical care. In so doing the pharmacist must have current specialized drug knowledge and demonstrate judgment communication skills self-direction and motivation to affect positive interventions in patient outcomes beyond those exhibited by those in a Clinical Pharmacist I position. Participate in educational programs as necessary to provide basic and advanced services of the Pharmacy Department. Additionally perform in the Clinical Pharmacist I role with its accountabilities and job activities pertaining to drug distribution supervision and non- dispensing functions.
Primary Duties and Responsibilities
Evaluates medication orders for accuracy and thoroughness. Resolves discrepancies of medication orders through communication with the physician clinical pharmacist or nursing staff and dispenses medication.
Assesses feasibility compounds or verifies the compounding of extemporaneous products. Recommends alternative products when appropriate.
Prepares IV admixtures and compounds sterile products including but not limited to: large volume parenteral mini-bags TPN solutions and hazardous agents including cytotoxic drugs.
Reviews patient profile to determine contraindications with the prescription. Screens drugs/dosages to assure appropriateness based on the therapeutic intent and the patient's physiological functions. Participates in monitoring drug therapy under the supervision of a clinical level pharmacist or above when working in a decentralized setting.
Dispenses controlled substances and maintains perpetual inventory of controlled substances assuring legal requirements and departmental policies and procedures are consistently followed.
Provides functional supervision for support personnel. Monitors attendance and work quality organizes and prioritizes resources based on workload and productivity and directs the workflow of support personnel. Ensures departmental standards and time frames are met.
Enters and verifies computer entries and data for drug orders. In decentralized setting may instruct patients/families on the safe use of medications and counsel them on potential adverse effects.
Monitors drug therapy of assigned patients and takes appropriate action to ensure optimum patient drug therapy drug selection and minimal adverse reaction. Assures drugs/dosages are accurate based on the therapeutic intent and the patient's physiologic functions. Reviews patient profile to determine possible contraindications with the prescription.
Participates autonomously in-patient care rounds. Reviews patient specific data to evaluate patient's status and medication needs and develops a therapeutic plan. Counsels/educates patient on their medications e.g. to correct dosing schedule and duplicate therapy.
Responds to evaluative and/or non-evaluative drug information requests.
Assures compliance of prescribers with clinical practice guidelines and other drug policies or third-party prescription benefit management procedures minimizes non-formulary drug use eliminates therapeutic duplication. Makes recommendations for appropriate alternative medications duplicate therapy and dosage changes.
Provides educational services including professional development of pharmacy technicians and the clinical pharmacists pharmacy residents nurses prescriber and other healthcare professionals.
Maintains own knowledge of current trends and developments in the field by reading literature attending related seminars and conferences and completing continuing education credits as required by the department.
Contributes to the achievement of established goals and objectives and adheres to department policies procedures quality standards and safety standards and MedStar SPIRIT Values. Complies with governmental and accreditation regulations.
Participates in meetings and on committees and represents the department and the hospital in community outreach efforts as appropriate.
Participates in multidisciplinary quality and service improvement teams.
Minimal Qualifications
Education
Doctoral degree from an accredited college of Pharmacy required or
Equivalent Pharmacy degree from an accredited college of Pharmacy required
Experience
PGY-1 or 3 years of direct patient care experience in a hospital setting required
Licenses and Certifications
PHARMD - Licensed Pharmacist in the state of practice required
Board certification within one year of eligibility within 1 Year required
Knowledge Skills and Abilities
Verbal and written communication skills. Basic computer skills preferred.
This position has a hiring range of : USD $120,702.00 - USD $238,222.00 /Yr.
We are looking for a Principal Thermal Rack Engineer within the Intelligent Infrastructure Segment to drive advanced cooling solutions for high-performance computing systems. This role involves incorporating thermal components such as direct liquid cooling (DLC) systems, coolant distribution units (CDUs), and manifolds into network and server racks (EIA 19” and ORv3). You will leverage CFD tools to perform rack and system-level thermal and fluid analysis, ensuring optimal flow distribution, pressure drop, and temperature performance. Additionally, you will create 3D CAD designs for seamless hardware integration, lead validation testing, and resolve thermal or flow issues through root cause analysis and corrective actions. Collaboration with cross-functional teams, customers, and global vendors is essential to align thermal architectures with overall system design and international standards.
Lead the end-to-end integration and testing of rack thermal solutions, including liquid cooling systems in varying form factors and product lines.
Use CFD tools (FloTherm or Macroflow) to perform switch, rack, and system-level thermal/fluid analysis (flow distribution, pressure drop, and temperature profiling).
Design and optimize thermal components using 3D CAD (Creo or SolidWorks) to support seamless hardware integration and testing.
Participate in customer engagements and site visits to understand and document deployment constraints and gather feedback for design improvements.
Partner with factory teams to ensure racks are built with proper airflow, hose routing, and thermal safeguards, while establishing best practices that improve build consistency across deployments.
Collaborate with Architects/Compliance/Reliability and global vendors to align thermal architectures with total system design and international data center/thermal/mechanical standards (e.g., Conduct thermal, mechanical, and reliability testing, analyzing airflow, coolant flow rates, pressure drops, and structural integrity to ensure compliance with the end-users’ specifications.
Develop and maintain design documentation including BOMs, wetted materials compliance, test plans, and engineering change orders (ECOs).
Manage relationships with mechanical/thermal component vendors to build out a robust partner ecosystem consisting of racks, CDUs, hoses, manifolds, QDs, and cold plates.
Ensure mechanical designs support airflow management, thermal containment, and integration with cooling systems (e.g., in-row cooling, in-rack cooling, rear door heat exchangers).
Conduct root cause analysis and corrective actions for mechanical and thermal failures or field issues.
Bachelor’s Degree in Mechanical/Thermal Engineering, Systems Engineering, or related field is required
Minimum of 7+years of experience in thermal/mechanical systems integration
~3+ years of specific experience in rack-scale thermal design and analysis
~ Strong understanding of mechanical systems, integration strategies, and large-scale program management
~ and 3D modeling software (e.g. SolidWorks, Creo)
~ Excellent English communication skills (verbal and written) with strong technical leadership capabilities
Creative, self-motivated, accountable, and team-oriented
Capable of assessing projects, articulating risks, and developing project milestones
Skilled in writing reports, business correspondence, and procedural guides
Effective at presenting information and responding to management and customers
Familiar with stage-gate processes in project lifecycle management (PLCM)
Ability to travel both domestically and internationally up to 30%
Master’s Degree in Mechanical Engineering, Systems Engineering or related field is preferred
Experience designing mechanical systems for data centers, telecom, or industrial power/cooling products.
Hands-on experience with prototype fabrication and testing; experience working with global suppliers and contract manufacturers a plus.
Headquartered in Austin, TX, with a flagship facility located near The Domain and the Austin FC stadium
Growing rapidly, with a team of more than 100 employees in Austin (500+ worldwide) and significant expansion planned through 2026
Generated over $12 billion in FY25 revenue, driven largely by partnerships with major hyperscale customers
Delivers cutting‑edge engineering, supply chain, and manufacturing solutions that power the world's AI infrastructure and global data center ecosystems
Annual bonus opportunity
~ Medical, dental, and vision insurance plans
~ 11 company-paid holidays (9 fixed holidays and 2 optional floating holidays), subject to change yearly
~401(k) retirement plan
~ Employee stock purchase plan
U.S. Army Orthopedic Surgeon protect the foundation of the Army by treating the foundation of Soldiers’ musculoskeletal systems.
If you are a professional in the field of Orthopedics and want to combine your passion for in this specialized field with a desire to serve your country, a career as an Army Orthopedic Surgeon might be the one for you.
Outstanding Opportunities
As a U.S. Army Orthopedic Surgeon, you will be able conduct both surgical and nonsurgical means to treat Soldiers, retirees, and their families with injuries and conditions involving the musculoskeletal system. Through your skills in diagnostic care, you will determine the best course of treatment when examining patients with disorders, malformations, disease or injury. You will also be able to utilize state-of-the-art equipment, go through continued education courses, seminars and trainings to advance yourself as a medical professional, and conduct research for the development of your field.
If you choose to serve in the Army Reserve, you will be able to serve your country as needed while still supporting your community.
Whether you choose to serve Active Duty or Army Reserve, a career as an Army Orthopedic Surgeon allows you to be all that you can be.
Outstanding Benefits
When you join the Army Medical Corps, you’ll be making a difference in the lives of our Soldiers and the country at large while gaining access to invaluable opportunities, like supporting humanitarian missions and leadership training, all while earning a competitive benefits package.
Benefits may include:
- Repayment of qualified education loans to lending institution, paid annually over a maximum of three years while serving
- Based on your field of concentration, you may be eligible for an accession bonus, paid over a four-year period while serving. You may also be eligible for special pay as a physician
- For Army Reserve, a monthly stipend through the Specialized Training Assistance Program (STRAP) for physicians currently enrolled in an accredited residency program
- Travel opportunities, to include humanitarian missions
- Up to 30 days of paid vacation earned annually
- Enrollment into the Uniformed Services Blended Retirement System
- No- to low-cost medical and dental care for you and your family
- Commissary and post exchange shopping privileges
- As an Active Duty Soldier, you may qualify to receive a monthly stipend through the Financial Assistance Program (FAP) while enrolled in an accredited residency program
- Specialized training to become a leader in medicine
Eligibility Requirements
- Must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited U.S. school of medicine or osteopathy
- Foreign graduates may apply if they have a permanent certificate from the Educational Council of Foreign Medical Graduates
- Must have a current license to practice medicine in the United States, District of Columbia or Puerto Rico
- Must be eligible for board certification
- Must have completed at least one year of an approved Graduate Medical Education (GME) internship
- Must be a U.S. citizen to serve Active Duty
- Must have a permanent U.S. residency for Army Reserve
Have questions or want more information?
To find out more information about becoming an Orthopedic Surgeon in the U.S. Army, visit . You may also reach out to your local Army Healthcare Recruiter to learn how you can get started on your journey as an Army Orthopedic Surgeon.
Join Our Team as an Academic Abdominal Imager at The George Washington University Medical Faculty Associates
Are you an experienced Abdominal Imager with a passion for academia and patient care? The George Washington University Medical Faculty Associates (GW MFA) is seeking a dedicated physician to join our prestigious Department of Radiology. This is a unique opportunity to teach, practice, and contribute to groundbreaking research in the heart of Washington, DC.
About GW MFA:
The GW MFA, established in July 2000, is a not-for-profit, physician-led practice group affiliated with The George Washington University School of Medicine and Health Sciences. As the largest independent academic physician practice in the Washington, DC metro area, we boast over 500 physicians and nearly 200 advanced practice providers, all committed to comprehensive patient care across 52 medical and surgical specialties.
Position Overview:
The GW University MFA Department of Radiology is seeking an academic Abdominal Imager to join our faculty. As an independent, non-profit academic clinical practice group, the MFA is strategically aligned with George Washington University. Responsibilities for this role include:
- Interpreting abdominal imaging studies
- Teaching medical students, residents, and fellows
- Participating in multidisciplinary clinical research
- Collaborating with our referring clinical colleagues and administrative partners
- Assisting with administrative functions of the department
Appointment to this full-time, non-tenure track position will be made at an academic rank (Instructor, Assistant Professor, Associate Professor, or Professor) commensurate with experience.
Qualifications:
- Board-certified or eligible in Diagnostic Radiology
- Completed an abdominal imaging fellowship or have significant experience in abdominal imaging
- Eligible for medical licensure in the District of Columbia
- Academic experience is required, and the ability to perform minor ultrasound-guided procedures is highly desirable
Living and Working in Washington, DC:
Embrace the vibrant culture and history of Washington, DC. Enjoy iconic monuments, world-class dining, and the beauty of the cherry blossoms. Proximity to the White House and numerous cultural institutions make DC a dynamic place to live and work. Our community-based practices extend across DC, Maryland, and Virginia, offering diverse living options.
Application Procedure:
Interested applicants should upload their CV and cover letter detailing their background and academic interests, including contact information, to our application portal. Only complete applications will be considered.
Equal Opportunity Employer:
The George Washington University and The George Washington University Medical Faculty Associates are committed to equal employment opportunities and affirmative action. We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or any other basis prohibited by law.
Join us and be a part of an esteemed academic tradition that values research, teaching, and compassionate care. Apply now and shape the future of radiology with GW MFA !
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Associate Project Leader
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.
Responsibilities
- Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
- Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
- Reviews, provides input on, and approves project and study documents and processes, as needed.
- Represents the project or company at client meetings and scientific conferences.
- Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
- Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
- Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
- Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
- Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
- Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
- Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
- Supervises, mentors, and supports lower-level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
- Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
- Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
- Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
- Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.
Qualifications
Education/Requirements
Associate Project Leader:
-Bachelor's degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO;
-Master's degree with at least 4 years of experience within pharma and/or CRO;
-PhD with at least 1 years of experience within pharma and/or CRO
Demonstrated working knowledge of the principles appropriate to the position with a typical tenure of at least 1 year management experience in a research environment.
Prior CRO/clinical trial management of late-stage clinical trials preferred
Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost
Demonstrated strong problem solving and analytical skills, combined with sound business judgment
Ability to work proactively and effectively, with creative problem-solving and collaboration skills
Highly motivated with ability to work independently and as part of a multi-disciplinary team
Strong cross-functional project management and time management skillsExcellent verbal and written communication skills
Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.
Responsibilities
- Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
- Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
- Reviews, provides input on, and approves project and study documents and processes, as needed.
- Represents the project or company at client meetings and scientific conferences.
- Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
- Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
- Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
- Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
- Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
- Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
- Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
- Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
- Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
- Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
- Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
- Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.
Qualifications
Education/Requirements
Project Leader: Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 years of experience within pharma and/or CRO
Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment
Prior CRO/clinical trial management of late-stage clinical trials preferred
Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost
Demonstrated strong problem solving and analytical skills, combined with sound business judgment
Ability to work proactively and effectively, with creative problem-solving and collaboration skills
Highly motivated with ability to work independently and as part of a multi-disciplinary team
Strong cross-functional project management and time management skillsExcellent verbal and written communication skills
Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
#LI-Remote
Safety Monitor II
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements.
Responsibilities
- Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members.
- Reviews safety events.
- Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
- Provides first line evaluation of serious adverse events (SAEs).
- Communicates with site staff regarding reported AEs or SAEs to gather additional information.
- Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
- Coordinates the timely completion and submission of required reports to health authorities and business partners.
- Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
- Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis.
- Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
- Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non interventional).
- Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary.
- Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports.
- Coordinates with project staff.
- Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
- Contributes to the development and implementation of safety related Case Report Forms (CRF) and SaMP.
- Ensures maintenance of documentation required by both corporate and project SOPs.
- Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
- Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
- Guarantees compliance and adherence to the quality standards.
- Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned.
- Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract.
- Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
- Completes all relevant professional training in the given scope and time frame.
- Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives.
Qualifications
- Bachelor's Degree in Pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice, example pharmacy, inpatient or outpatient healthcare facility, or clinical research center.
- 1-3 years in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) required
- Experience in safety monitoring/pharmacovigilance preferred
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
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