Senior Project Manager

Summary

Join our team as a Senior Project Manager - Oncology and lead the cross-functional operations of assigned studies. You will manage a portfolio of projects, ensuring on-time and within-budget delivery while maintaining high quality. This role requires strong leadership, communication, and problem-solving skills within a clinical research setting, specifically with oncology projects. Experience in managing oncology projects, particularly in cell therapy or CAR-T, is essential. The position involves close collaboration with clients, team members, and investigative sites, requiring up to 25% travel.

Requirements

• University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology
• 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
• Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials
• Excellent written, oral communication and presentation skills
• Excellent interpersonal and organizational skills with demonstrated attention to detail
• Ability to read, write and speak fluent English
• Ability to build positive, productive client and team member relationships
• Demonstrated problem-solving capabilities, critical thinking, and analytical skills
• Good computer skills with good working knowledge of a range of computer applications
• Ability to meet deadlines, multitasks, and prioritize based on project needs
• Ability to make sound decisions based on available information
• Ability to work both in a team and independently
• Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes
• Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%

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, including therapeutic, protocol specific and process training
• 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 and directly assist with such activities as needed
• Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs
• Oversee 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