The Clinical Program Manager will provide clinical study management and cross functional leadership for diagnostic product development in support of GRAIL clinical development and commercial strategies. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as managing clinical project timelines, budgets, deliverables, and overall communications.
- Overall operational oversight of assigned clinical studies including but not limited to investigator selection, analysis and establishment of enrollment strategies, and preparation of studyrelated documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements).
- Work with senior management to develop project timelines, study budgets and project management plans; report to all stakeholders at regular schedule on project status.
- Participate on product development program teams as the clinical representative for assigned projects; leads clinical study execution teams and serves as point person for communications with program teams.
- Works with business development to identify and select consultants, vendors, contract research organizations (CROs), etc.; responsible for overall management of vendors/CROs and study monitoring.
- Creates and implements departmental procedures (including project management processes and SOPs) in compliance with industry standards and regulatory requirements Responsible for the oversight of the ongoing maintenance of the Trial Master File.
- Monitors compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities.
- Organizes the writing and review of clinical sections of regulatory submissions and product labeling and ensures compliance with applicable regulations
- Management of multiple clinical studies in parallel, through direct reports and/or other support staff, as appropriate