We have an exciting opportunity open for a Sr. Clinical Trial Manager who will be responsible for the day-to-day operational oversight of oncology clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements.
- Manage and monitor clinical studies from site selection and initiation through data collection and site closeout. Ensure studies are conducted in accordance with protocol, standard operating procedures, good clinical practice and regulatory requirements
- Liaise with investigators, coordinators, and site study team to conduct trails
- Validate study information by monitoring and tracking clinical study data including: CRFs, source documents, laboratory reports, inventory logs, etc.
- Contribute to developing clinical protocols, case report forms, informed consent documents, draft source documents, patient instruction guides, case report forms, and other study aids for investigational products by addressing issues from a monitoring perspective
- Facilitate in all operational activities pertaining to the execution of clinical trials
- Responsible for completion of study deliverables
- Ensure applicable regulatory requirements are maintained in the execution of all activities
- Evaluate operational feasibility and recommends study execution plan
- Develop and manage comprehensive study timelines and metrics
- Manage staff including recruiting, hiring, motivating, performance management, training and development
- Writes clinical protocols and participates on interdepartmental project teams