Senior Project Manager

Summary

The Senior Project Manager - Oncology is responsible for managing assigned studies for one or more clients with minimal supervision. The role requires a university/college degree in life sciences or a related allied health profession, 7 years of experience in a Project Manager role in a clinical research setting, and strong knowledge of the drug development process and FDA regulations.

Requirements

• University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution
• 7 years previous experience in a Project Manager role in a clinical research setting with a progression of increased responsibility over time
• Experienced managing oncology projects- working in either cell therapy or CAR-T

Responsibilities

• Responsible for the overall coordination and management of clinical trials from start-up through close-out activities
• Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials
• Facilitate team training in accordance with the protocol and/or project requirements
• Direct all project staff across functional areas to facilitate study progress
• Develop study specific Standard Operating Procedures (SOPs) and other study-specific management tools as needed
• Oversee activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies
• Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation
• Oversee the negotiation, or may negotiate, of the site contracts and/or budgets as well as distribution of investigator grants
• Oversee the supply of Investigational Product and other study materials to sites
• Work with sponsor to determine and implement patient retention strategies as needed
• Assist with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues
• If part of the role, monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs
• Ensure project documentation is complete, current, stored appropriately and audit-ready
• Develop and maintain a close working relationship with sponsor study management team
• Establish a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters
• May serve as the primary liaison with the sponsor and project team for assigned studies
• Coordinate, plan and execute Investigator Meetings as needed. May need support from a Senior Project Manager
• Lead internal project team meetings
• May lead sponsor project team meetings or collaborate with a Senior Project Manager
• Oversee the creation and distribution of study-specific newsletters as required
• Escalate issues and critical project matters in a timely manner to appropriate team members, senior management, and sponsor