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Clinical Trial Managerstudies.
Responsibilities include, but are not limited to:
Manage CRO/vendor interactions including sponsor oversight of all delegated responsibilities, scope revisions/contract amendments, budgets and invoices, detailed timelines, and ensuring all expectations have been met.
Review and/or preparation of study related documents, such as Laboratory Manuals, Pharmacy Manuals, CRF completion guidelines, model informed consent forms, protocol amendments, etc.
Clinical trial supply ordering and tracking.
Monitor study progress, review emerging clinical data, and ensuring that data retrieval and clean-up is completed on schedule.
Maintain regular contact with personnel at clinical investigative sites and/or CROs.
Conduct co-monitoring visits as needed.
Ensure that assigned clinical trials are executed in compliance with applicable regulations, guidance and SOPs. Travel to vendor and investigative sites to conduct on-site QC visits at clinical trial vendor facilities and investigative centers.
Applying candidates must have a Bachelorís degree in a scientific discipline or the equivalent, with 5+ years of clinical research experience at either a Sponsor or CRO, including at least two years as either a clinical project manager/clinical trial manager or other comparable position. Prior experience directly monitoring and managing cancer clinical trials is strongly preferred. Availability to travel up to 25% or more, depending on project needs, is required.
The ideal candidate possesses knowledge and appreciation of all stages of pharmaceutical drug development, analytical operations, compliance and documentation. He/She must have demonstrated leadership skills with ability to work independently and within high performance teams.
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