Associate Project Manager
About The Position
The Associate Project Manager plans, organizes, communicates, implements, and evaluates team objectives, serves as the sponsor point of contact, and manages the day-to-day operations of the project management department and assigned projects. The role works with Foundation sponsors and internal departments and project teams to create and execute project plans, revising them as requirements change. The Associate Project Manager reviews team deliverables, enforces project standards, and is responsible for project accounting, budgets, revenue recognition, invoicing, receivables, expense and hour tracking, and financial and performance reporting. The role analyzes revenue, expenses, margins, bill rates, utilization, capacity, project profitability, and contribution to the Foundation, and ensures the department has adequate tools. The position leads development of clinical trial project deliverables and sponsor interactions, coordinates Foundation teams, and manages multiple trials from start-up through closeout. It ensures adherence to Foundation procedures, GCP, and applicable regulations; communicates operational updates and key performance indicators; and coordinates matrixed functions including Biometrics, Device/Drug Safety Information, Core Labs, Financial Management, Information Technology, Regulatory, and Quality Assurance. It may also assist with staff training programs in research conduct, safety, data management, budgeting, quality assurance, and regulatory compliance. The role follows a flexible hybrid arrangement requiring at least two predetermined days per week in the mid-town office. Occasional evening and weekend work may be needed to meet research trial deadlines.
Requirements
- Bachelor’s degree, preferably in a medical or life sciences field, and at least 2 years of related clinical research experience in a pharmaceutical, medical device, or CRO environment; alternatively, an MBA and 1 year of related clinical research experience in such an environment.
- Proficiency with Microsoft Outlook, Word, MS Project, and Excel.
- Ability to analyze information and solve problems involving information from Case Report Forms (CRFs).
- Expert knowledge of GCP/ICH guidelines and FDA regulations.
- Comprehensive understanding of drug development and the medical device process.
- Excellent communication and writing skills, patience, professionalism, and ability to interact effectively with staff and management.
- Ability to communicate verbally with department heads, medical leadership, and other team members.
- Ability to multitask and work with users under deadlines; set priorities and manage time effectively.
- Ability to accurately project task completion time and communicate estimates to project teams.
- Flexibility and willingness to occasionally work evenings and weekends to meet research trial deadlines.
- Ability to analyze information and make decisions when information conflicts.
- Experience and/or knowledge of US and OUS clinical research regulatory matters, including IDE and IND submissions, adverse event reporting, Good Clinical Practices, and Good Documentation.
Nice To Haves
- Clinical research experience in cardiology is preferred.
- Previous project management experience is preferred.
- Experience at a large pharmaceutical or medical device company is desirable.
- Experience as a lead CRA on a large global clinical trial is desirable.
- Certified Associate Project Management (CAPM) certification or equivalent is preferred.
Responsibilities
- Lead development of project deliverables, including project management plans, clinical budgets, study timelines, risk and contingency plans, monitoring plans, and communication plans.
- Lead interactions with study sponsors and coordinate Foundation teams according to agreed timelines and budgets.
- Ensure compliance with Foundation policies, procedures, SOPs, GCP, and local, regional, and federal regulations.
- Manage day-to-day operations of multiple clinical trials, including start-up, conduct, and closeout.
- Provide requested updates and reports; communicate operational issues and provide key performance indicators to study teams and sponsors.
- Participate in project team meetings.
- Prepare project plans and guidelines for implementation.
- Maintain professional expertise through familiarity with clinical literature.
- Manage project components across Biometrics, Device/Drug Safety Information, Core Labs, Financial Management, Information Technology, Regulatory, and Quality Assurance to support project success.
- Develop target timelines with department heads and prepare project plans.
- Ensure trial-specific guidance documents follow Foundation SOPs and sponsor expectations.
- May assist in administering and developing staff training programs in research study conduct and safety, data management, clinical research budget constraints, quality assurance, and regulatory compliance.
- Track and report team hours and project expenses; prepare reports for project teams and management.
- Manage project budgets and accounting, including revenue recognition, invoicing, and receivables monitoring.
- Analyze revenue, expenses, margins, bill rates, utilization, capacity, profitability, and project contribution to the Foundation.
- Perform additional duties as assigned.
Benefits
- Choice of medical, dental, and vision health plans
- Company-paid short-term and long-term disability insurance
- Company-paid life insurance
- Health and dependent care flexible spending accounts
- Pre-tax travel expenses through the TransitChek program
- 401(k) plan
- Generous paid time off (PTO)
- Ten paid holidays each year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
