Clinical Trial Manager

Location
San Diego, CA, United States
Posted
Nov 04, 2020
Ref
348SW
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate's Clinical Operations team is currently seeking a talented and motivated clinical operations professional to support our clinical trials. The successful candidate must have experience managing Phase I-III trials and a good knowledge of clinical operations, GCP and FDA regulatory environment. Oncology trial experience preferred. This is a full-time position reporting to the Director / Associate Director, Clinical Operations, and is located at our Company's headquarters in San Diego, California or in South San Francisco, California.

Responsibilities:
• Study management and GCP vendor oversight in day to day clinical operations. May be
responsible for multiple clinical projects in various stages of development.
• Oversee study subject enrollment and monitoring activities at participating clinical sites.
• Designated team leader responsible for coordination of project activities and project
goals.
• Responsible for Trial Master File implementation and maintenance.
• Develop study documents and tools including study protocols, consent forms, project
plans, budgets, logs, templates, newsletters, and other, as needed.
• Develop SOPs and best practices and facilitate their implementation.
• Provide study status updates and reports.
• Conduct 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.
• Perform and/or oversee monitors delegated to perform tasks related to site
qualification, initiation, interim monitoring, and close-out visits, as needed.
• Develop and deliver study training to investigators, site staff, and internal staff on select
study processes.
• Develop processes and provide oversight of study supplies management.
• Conduct internal meetings for assigned clinical trial(s) and prepare minutes, as
necessary.
• Conduct 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.

Qualifications
• B.S. degree with minimum 5 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 (solid tumor, lymphoma or multiple myeloma experience
highly preferred).
• Immunotherapy or cellular therapy 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
• Full-time onsite work at Company's headquarters in San Diego
• Minimum 10% 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 from time to time. For consideration send cover letter and resume to: careers@fatetherapeutics.com and reference job code 348SW.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. 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 product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.