Catalyst Clinical Research is hiring a
Senior Project Manager
closedCatalyst Clinical Research
π΅ ~$182k-$234k
πRemote - Worldwide
Summary
The Senior Project Manager - Oncology role involves managing clinical trials for one or more clients with minimal supervision, ensuring successful delivery of studies on time, within budget, and according to sponsor/CRO expectations. The position requires a university 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 drug development process, FDA regulations, ICH GCP guidelines, and excellent communication skills.
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
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
This job is filled or no longer available
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