The Senior Clinical Trials Manager (Sr. CTM) will be a member of the client’s Clinical Operations team.
Key Accountabilities:
Oversight of activities
- Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.
- Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials
- Provide direction and leadership in CRO and vendor selection and management.
- Knowledge of regulatory start up process and planning in support of study start up
- Managing and maintaining high performing clinical teams
- Coordination of global clinical trials
- Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
- Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
- Be responsible for and manage clinical research activity of Clinical Operations team
- Estimate, track and critically analyze vendor financial spend on study
- Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
- Provide guidance, direction, and management to site monitoring activity
- Coordinate patient enrollment activities and mitigation planning
- Coordinate study supplies with regulatory and clinical supplies functions
- Negotiate contracts with vendors of clinical trial services
- Review Informed Consent Forms, CRFs, and study related materials
- Plan and participate in investigator meetings
- Assist and support data query process
- Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines
- Ensures trial master file is current and maintained
Collaborative relationships
- Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. Collaborate in the development of programming specifications.
Skills:
- Excellent oral and written communication skills and strong organizational abilities
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
- Demonstrated ability to work independently and in a team environment
- Ability to prioritize and manage multiple tasks simultaneously.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Knowledge and Experience:
- Proven experience of clinical trial management
- Proven management of people in a matrixed environment
- Experience in CNS and / or oncology is preferred
- Management of global clinical trials
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
- Travel required. Must be willing to travel 15-25%, including international travel.
- Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
Education:
- BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
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