CLINICAL PROGRAM MANAGER
CLINICAL PROGRAM MANAGER
GRAIL, Inc., is a discovery-stage life sciences company that is developing differentiated platforms for the early detection of cancer. GRAIL’s research programs combine approaches to ultra-deep sequencing of circulating, cell-free nucleic acids with innovative clinical programs of the scale and quality required to generate strong scientific and clinical evidence of their utility. GRAIL’s software and computational biology efforts are commensurate to the size and complexity of the resulting data sets. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.
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.
TASKS AND RESPONSIBILITIES
- 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
- Bachelor’s degree or equivalent in the life sciences or related field required; advanced degree (Master’s or above) preferred. Additional coursework in clinical trial planning and execution strongly desired.
- 7+ years’ functional experience with managing clinical trials, including risk assessment and contingency planning.
- Demonstrated strong track record of management of clinical operations staff and team leadership, as well as internal and external communications
- Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience can substitute in part for IVD experience.
- Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
- Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills
- Data management experience and knowledge of statistical principles as applied to clinical trials highly desirable.
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Familiarity and ability to work with office automation programs and corporate database tools.
- Strong work ethic and demonstrated ability to deliver assignments on time
- Ability to travel as required (up to 25%)
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.