Senior Clinical Project Manager - Oncology

September 18

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Catalyst Clinical Research

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

201 - 500

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 • Oversee negotiation 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 • 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 • 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 • Oversee the creation and distribution of study-specific newsletters as required • Escalate issues and critical project matters in a timely manner

Requirements

• University/college degree (life sciences preferred) or certification in a related allied health profession • 7 years previous experience in a Project Manager role in a clinical research setting • 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, 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 • Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%