Description:
The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Role And Responsibilities
- Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
- Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
- Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
- Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
- Proactive identification and management of study related risks
- Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
- Responsible for reviewing and managing study related plans, processes including
- Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
- Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
- Reviews and approves essential document packages to enable timely site activations
- Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
- Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
- Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
- Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
- Perform periodic QC of the TMF
- Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
- Ensures the study is “inspection ready” always
- Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
- All other duties as assigned