Associate Clinical Trial Manager
Fates Clinical Operations team is currently seeking a talented and motivated clinical operations professional to support our Oncology clinical trials. The successful candidate must have experience managing trials and a good knowledge of clinical operations, GCP and FDA regulatory environment. Oncology trial experience required. This is a full-time position reporting to a Director, Clinical Operations, and is located at our Companys headquarters in San Diego, California or remotely from the San Francisco, California area.
- Support primary Clinical Trial Manager with study management and GCP vendor oversight in day to day clinical operations. May be responsible for multiple clinical projects in various stages of development.
- Support study start-up and close-out activities at participating clinical sites.
- Support study subject enrollment and monitoring activities at participating clinical sites.
- Coordinate project activities and project goals.
- Support Trial Master File implementation and maintenance.
- Assist in the development of study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and other documents, as needed.
- Assist in SOP development and best practices and facilitate their implementation.
- Provide study status updates and reports.
- Assist in ongoing study data reviews and data cleaning activities.
- Interact efficiently and professionally with participating study sites staff, internal staff, and other departments to ensure smooth study conduct.
- Assist primary Clinical Trial Manager in support and oversight of monitors delegated to perform tasks related to site qualification, initiation, interim monitoring, and close-out visits, as needed.
- Assist in the development and delivery of study training to investigators, site staff, and internal staff on select study processes.
- Assist with study supplies management.
- Participate in internal meetings for assigned clinical trial(s) and prepare minutes, as necessary.
- Participate in external meetings (e.g., Investigator Meetings), conferences and events.
- Interface with representatives from other key functional groups including research and development, regulatory, quality, and legal as appropriate.
- B.S. degree in life sciences, pharmaceutical sciences or equivalent with minimum 2 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
- Good knowledge of clinical operations and experience with clinical study conduct from start-up through close-out.
- Oncology experience required (lymphoma or multiple myeloma experience highly preferred).
- Immunotherapy or cellular therapy experience highly preferred.
- Clinical site monitoring experience highly preferred.
- Working knowledge of relevant GCPs and FDA regulations.
- Experience operating in a matrix organization.
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
- Strong team orientation, with excellent written and oral communication skills.
Working Conditions and Physical Requirements:
- May require occasional evening and weekend work
- Fulltime on-site work at corporate headquarters in San Diego, CA or from the San Francisco Bay area
- Up to25% time traveling to clinical sites and clinical/professional meetings
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first- in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.