Job Title: Senior Project Manager
Location: Philadelphia, PA
Type: Direct Hire
Compensation: $160,000.00 depending on experience
Work Model: Hybrid - onsite and remote (1 day a week onsite, but occasionally more could be required)
Hours: 40.0
Responsibilities - Manage the overall planning, execution, and close-out of oncology clinical trials, ensuring all aspects are completed on schedule and within budget.
- Coordinate between funders, project teams, and external stakeholders to facilitate communication and project alignment.
- Review contract documents, protocols, budgets, and Case Report Forms (CRFs) to develop project scopes.
- Supervise development of cross-functional project teams including Medical, Data Management, Regulatory, Monitoring, and Clinical Supplies departments.
- Oversee the creation and implementation of detailed project plans and Standard Operating Procedures (SOPs).
- Provide guidance on issue resolution, ensuring timely and effective solutions.
- Monitor project budgets and resource allocations, maintaining compliance and reporting to management and fiscal personnel.
- Ensure clinical trial practices meet federal regulations, report data accurately, and address queries promptly.
- Distribute protocol amendments, updates to the Investigator's Brochure, and communicate significant adverse effects or risks to all participating sites.
- Mentor and train junior staff, including Project Managers, Associate Project Managers, and CRAs.
- Maintain positive communication with funders' representatives and attend relevant meetings with sponsors and organizational staff.
- Provide regular status updates to sponsors and senior leadership, flagging any issues affecting patient safety or project timelines.
- Assist in preparing proposals for new contracts, including resource planning for project management and monitoring.
Requirements - Minimum of ten (10) years of experience in healthcare, with a focus on oncology clinical trial management and/or data management services.
- Proven experience in pharmaceutical industry, CRO, or multisite trial environments.
- Proficiency in Microsoft Office, especially Excel, and related project management systems.
- Bachelor's degree from an accredited institution; Master's degree and SOCRA certification preferred.
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
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Ref: #568-Clinical
