Clinical trial Managers
Clinical Trial Manager will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report. Manages all aspects of the study and ensures clinical trials are executed in compliance with international GCP (Good Clinical Practice) guidelines/regulations and SOPs.
- Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables
- Responsible for selection, qualification, and management of vendors to support clinical trial execution
- Proactively identifies and resolves clinical project issues
- Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel
- Plans, executes, and leads study-specific meetings
- Provides input for the design of the Informed Consent Form(s), CRFs, monitoring conventions, edit checks, etc.
- Reviews monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Uses operational and therapeutic expertise to optimize trial design and execution
- Collaborates with the Director to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment
- Participates in site monitoring visits as applicable
- Cultivates relationships with investigators and site staff; critical to be comfortable engaging KOLs in scientific discussion
- BS/BA in life sciences preferred
- 5 years of direct experience in clinical trial execution
- Experience managing clinical trials both fully outsourced as well as managed directly
- Excellent communication (verbal and written), organizational and problem solving skills
- Prior experience developing and managing clinical trial budgets
- Oncology experience
- Experience managing external contract research relationships.
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