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Associate Clinical Project Manager (DVC)

General Dynamics Information Technology • Fairfax, VA • 3h ago

Req ID: RQ206978

Type of Requisition: Casual

Clearance Level Must Be Able to Obtain: None

Public Trust/Other Required: None

Job Family: Science and Research

Skills:

Biotechnology,Clinical Quality Assurance,Clinical Research,Regulatory Compliance

Experience:

5 + years of related experience

Job Description:

GDIT's Federal Health team is hiring a part-time, casual Associate Clinical Project Manager to support Dynport Vaccine Company.

HOW YOU WILL MAKE AN IMPACT:

Responsible for oversight of CRO's site management, and/or data management and/or monitoring aspects of assigned trial(s) to ensure compliance with ICH GCPand per transfer of regulatory obligations (TORO).

Assist in writing assigned portions of a protocol, protocol amendments, informed consent forms (ICF), various forms/templates/procedures, and/or other trial documents as assigned.

May assist in preparing and reviewing Statements of Work (SOWs) and Request for Proposals (RFPs)/Bid responses.

Perform ongoing review of project monitoring status and identifies possible project risks.

Implements risk mitigation solutions as appropriate.

May participate in delivery assurance/integration reviews with key stakeholders to ensure adherence to contracted client deliverables/milestones, timelines, costs and quality.

Assist in organizing project team members to ensure communication and understanding of deadlines for assigned objectives.

Work in conjunction with team members and stakeholders to manage changes to technical requirements, business requirements and schedule of the project.

Provide input to management on possible changes needed based on current project status.

Work with Clinical Quality Assurance to ensure trial compliance with applicable regulations (ICH-GCP, 21CFR).

WHAT YOU'LL NEED TO SUCCEED:

Bachelor's Degree or equivalent clinical research related experience.

Minimum of 5+ years of progressing clinical research experience in the academic, industryor government sectors.

Experience monitoring or providing monitoring oversight of clinical trials.

WHAT WOULD BE EVEN BETTER:

Previous experience supporting DVC with quality assurance.

20+ years of regulatory compliance and clinical quality assurance

The likely hourly rate for this position is between $51.85 - $70.15. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. GDIT typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year. Paid leave and paid holidays are prorated based on the employee's date of hire. The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

Join our Talent Community to stay up to date on our career opportunities and events at https://gdit.com/tc.

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

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