Senior Clinical Trial Manager - US or Canada - FSP
About The Position
The Senior Clinical Trials Manager (Sr. CTM) will be a member of the client’s Clinical Operations team. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™
Requirements
- Proven experience of clinical trial management
- Proven management of people in a matrixed environment
- 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)
- 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.
Nice To Haves
- Experience in CNS and / or oncology is preferred
Responsibilities
- 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
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
