Clinical Operations Manager
San Diego Metro Area, CA
- Clinical Operations Leader
The primary role of the Clinical Operations Leader is to coordinate, manage and supervise operational activities associated with clinical development programs, including: maintenance of essential study documentation, dissemination of key information to clinical advisors, CROs and ancillary vendor partners and participating investigators; establishing and managing contracts and budgets with clinical investigators and clinical trial service providers; preparing clinical trial documents (e.g., protocols, investigators brochures, site operations manuals) and; ensuring that these activities are conducted in accordance with all applicable regulations, and ICH and GCP guidance standards. In addition, this individual may prepare departmental standard operating procedures, working procedures and templates. This role is also responsible for tracking and reporting budgets and timelines for clinical programs.
This position requires a proven track record of increasing responsibility in clinical operations, and successful management of clinical research and support personnel, departmental budgets and timelines in the pharmaceutical/biotech industry.
Experience with large, complex late stage global clinical development programs required. NDA filing and therapeutic experience in a related field highly desired.
Evaluate potential contract research organizations (CROs), vendors and other service providers for use in clinical studies.
Ensure qualification of CROs, vendors and service providers in accordance with SOPs.
Supervises Clinical Trial Managers (CTMs) and/or Clinical Research Associates (CRAs).
Manage vendors providing the operational functions of Receptos clinical programs. Participate in functional guidance, training, education and evaluation of vendors personnel.
Supervise the activities of CROs, contractors and other vendors as they are related to the clinical programs.
Ensure screening and evaluation of potential Investigators to ensure compliance with regulatory and corporate requirements.
Supervise negotiation of Investigator agreements and grants appropriate to the clinical programs.
Ensure review and approval of written reports of all site monitoring visits prepared by CRAs to ensure they are completed in a timely fashion and according to Federal regulations, GCP and SOPs.
Ensure maintenance of essential documents associated with Receptos clinical trials, in accordance with applicable regulations and international guidance s.
Participate in corporate committees, task forces, technical or business meetings as requested.
Ensure timely and appropriate response to clinical investigator site issues or other study management problems. Ensure maintenance of documentation in appropriate reports of all communications, particularly those in which patient or protocol issues are discussed.
Prepare communication and status reports to provide updates/information to senior management.
Direct clinical operations activities in preparation of interim analyses, clinical study reports, annual reports and other clinical documents.
Demonstrate mastery of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
Develop and maintain departmental standard operating procedures (SOPs) in collaboration with Clinical Development, Regulatory Affairs and Quality Assurance.
Establish and maintain good relationships with Investigators, advisors, other study personnel, clients and vendors.
Attend seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc.
Other duties as assigned.
Knowledge, Skills and Abilities Required:
Bachelor s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study.
Knowledge of medical terminology required.
Computer literacy (Word/Excel), familiarity with clinical database concepts, and experience with statistical principles is required.
Position may require travel expected to be no more than 20% (domestic and international).