Clinical Site Manager
Bellicum Pharmaceuticals is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.
Bellicum has an outstanding opportunity for an Clinical Site Manager (CSM). This role can be remote, or out of our office in San Francisco or Houston. The the Clinical Site Manager, reporting to the Associate Director, Clinical Site Management, is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The CSM is responsible for implementing and executing clinical trials at the sites assigned under his/her responsibility. He/she should ensure compliance with international guidelines, local regulations and corporate policies and procedures.
Specific Job Duties
- Successfully implements and executes phase I – III clinical trials at their assigned sites and builds positive working relationships with principal investigators and site personnel.
- Coordinates logistics of Bellicum product readiness with sites and internally within Bellicum; working cross-functionally with manufacturing, QA, supply chain management, etc. to coordinate site training, product delivery, supply management, etc. to ensure readiness and product availability prior to patient treatment/dosing.
- Maintains quality and reliability of study as measured by data quality parameters, e.g. needed data clarifications, lost or missing data and overall protocol compliance.
- Ensure all safety issues are communicated and managed by Principal Investigator and study team in the appropriate timelines to the Medical Monitor as per protocol and GCP/ICH requirements.
- Manage negotiation, finalization, accounting and tracking of investigator Clinical Trial Agreements, budgets, payments both at the site and subject level.
- Manage monitoring progress of contract CRAs; review and approve all CRA timesheets and invoices.
- Conduct review and approval of site monitoring visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
- Ensure compliance with regulations, guidelines and policies for studies implemented at their assigned sites and manage site level Trial Master File(s).
- Collaborate and actively participate within the Clinical Trial Teams (CTT) to proactively identify and resolve site, quality or study execution issues.
- Ensure Monitoring and Data Review Plans are in place for assigned trials and that all monitoring activities are conducted according to study plans, relevant Bellicum processes and standard operations procedures (SOPs), GCP/ICH guidelines and other regulations.
- Ensure all trial monitors receive appropriate protocol and therapeutic training. Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct for biologics, and uses that knowledge to enhance site compliance and performance.
- Chair Investigator meetings and ensure meeting minutes are completed and filed in the Trial Master File (TMF).
- Maintains positive site relations on behalf of Bellicum; fosters good working relationships both internally and externally.
- Senior CSM: May supervise trial monitors/other CSMs and conduct Quality Standards Visits with monitors to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance.
Skills, Minimum Education, and Experience
- BS in the life sciences or related discipline, at minimum
- 5 or more years in clinical operations at site or sponsor; experience monitoring sites and conducting other site management activities
- Therapeutic experience in oncology, cellular/transplant therapy strongly preferred
- Experience in early phase trials (Phase I-II) and First-In-Man studies
- Additional requirements include strong site and CRA management skills and communication skills. Ability to work both independently and as part of a team demonstrating excellent communication and interpersonal skills is required.
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
- Must be willing to travel to Houston occasionally.