Senior Clinical Project Manager​/Medical Affairs - Remote

Senior Clinical Project Manager/Medical Affairs - Remote

Position: Senior Clinical Project Manager/Medical Affairs

Location: Franklin Lakes, NJ

Duration: 6 Months

Hours per week: 40

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Clinical

Experience Level: Senior Level

Employment Type: Contract on W2 (US Citizens or Green Card holders, EAD, CPT, etc.)

• Medical Affairs (MA) plays a critical role in new product development, including Key Opinion Leader engagement on innovative technologies; user needs, requirements, and hazard identification, all to ensure product safety and efficacy. MA also contributes significantly to post‑market risk estimation criteria, risk‑benefit analysis of products, Clinical Evaluation Reports, and literature searches.
• Reporting within Specimen Management Clinical Operations Medical Affairs, the Clinical Project Manager is responsible for Human Subject Research trial management (clinical, non‑clinical, and administrative functions) across multiple studies.
• This individual may serve as a subject matter expert for a group or platform of assigned clinical studies, including planning, implementation, oversight, project management, and completion of Human Subject Research conducted by Specimen Management (SM) Medical Affairs or a Contract Research Organization (CRO), if applicable.
• As the project lead for studies of moderate to high complexity, from protocol development through study conduct and closeout, the Clinical Project Manager ensures compliance with Good Clinical Practices and all Global, National, and Local Regulations. The role collaborates with cross‑functional teams, including Data Management, Statistics, and other members of the SM Medical Affairs team, to evaluate and/or develop clinical studies.
  
  This position may directly or indirectly (matrix) manage professional employees, business support, or technical staff.

• Prepares and/or reviews study‑related or essential study start‑up documents as they relate to the assigned human subject research trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, and other relevant study plans and charters).
• Serves as a Sr. Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team.
• Responsible for scheduling and running study team meetings and generation of meeting minutes and other study‑related documentation.
• Oversees/leads study‑specific study management resources.
• Accountable for setting own work direction and completing work tasks assigned by leadership team.
• Develops and manages group of studies for an entire business unit or large development program.
• Provides critical thinking and leadership when issues arise during execution of clinical studies, including risk management and mitigation actions.
• Leads or contributes to continuous improvement activities/initiatives.
• Manages relationships with sites/PIs and other study related vendors, including CRO’s.
• Intermediate knowledge of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
• Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, progress, risks, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
• Adapts work package deliverables based on study scale and complexity.
• Creates aggressive but achievable resource and budget forecasts and timelines.
• Has accountability for good stewardship of financial resources for personal and project expenses.
• Interacts with both Internal and External contacts, providing direction to the Global Clinical Affairs (GCA) cross‑functional team members and vendors (if applicable) regarding the technical, protocol‑specific and operational aspects of assigned studies.
• Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost‑effective…