Associate Clinical Trial Manager

Location
San Diego, CA, United States
Posted
Sep 09, 2020
Ref
402MD
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 Hematology/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 the Associate Director, Clinical Operations, and is located at our Company's headquarters in San Diego, California or remotely from the San Francisco, California area.

Responsibilities:
• 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.

Qualifications
• B.S. degree 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
• Full-time onsite work at Company's headquarters in San Diego or remotely from the
San Francisco, CA area
• Up to 25% 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 402MD.

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.