Senior Project Manager

December 20, 2024

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Catalyst Clinical Research

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Catalyst Clinical Research is a specialized clinical research organization with a focus on oncology and multi-therapeutic functional service provision for the global biotechnology and biopharmaceutical industries. Through their Catalyst Oncology division, they offer full-service oncology clinical research support, tapping into an extensive site network and experienced global teams to aid cancer drug development. Meanwhile, Catalyst Flex provides specialized functional solutions across clinical operations, data management, biostatistics, and medical writing to strengthen and customize clinical trials. As a partner in drug development, Catalyst Clinical Research delivers flexible, customizable solutions to meet the diverse needs of biotech companies, emphasizing efficiency and innovation in research.

Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• 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. • Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation. • Oversee negotiation, or may negotiate, of 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. • 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 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. • Lead internal project team meetings and may lead sponsor project team meetings.

🎯 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. • 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. • 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, multitask, 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%.