Associate Director / Senior Manager, Clinical Trial Operations

Location
San Diego, CA, United States
Posted
Sep 04, 2020
Ref
368SW
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
Fate Therapeutics is seeking a clinical operations professional to support our clinical programs by providing management and oversight of Clinical Trial Associates (CTA)s and to ensure timely and quality management for the electronic trial master file (eTMF). This role will be responsible for hiring, managing, training and development for our CTA staff across all trials with experience supporting the standardization, training, quality and timely clinical trial documentation across multiple clinical programs. The successful candidate will work closely with cross functional teams including clinical development, legal, finance, regulatory affairs, quality assurance, and IT. This is a full-time position located at our corporate headquarters in San Diego, CA reporting to the Senior Director, Clinical Business Operations.

Responsibilities
• Recruit, manage, mentor, train and develop CTA staff and systems specialist staff.
• Oversee development and maintenance of Veeva eTMF process and configurations.
• Oversee set-up, development and maintenance of clinical system process and configurations, such as for a Clinical Trial Management System (CTMS) or Interactive Response Technology (IRT).
• Collaborate with internal clinical operations team members to develop process and plans for eTMF, CTMS and IRT set-up and management.
• Provide input into clinical operations processes and SOPs to ensure adherence to GCP/ICH consistency and quality, with emphasis on CTA activities and systems set-up, validation and maintenance.
• Partner with clinical operations to ensure the clinical trial associate team is sufficiently staffed and properly trained and equipped to provide continuous support activities for all assigned clinical trials.

Qualifications
• Minimum of 5 years of experience in clinical operations role and a BS / BA in a relevant scientific discipline.
• Experience managing clinical operations staff with focus on clinical trial support, eTMF maintenance, and other clinical systems.
• Extensive experience with eTMF maintenance, with Veeva Vault experience.
• Experience with CTMS and IRT system set-up and maintenance.
• Experience with validation of clinical systems.
• Experience working with CRO / FSP partners and clinical trial sites supporting global clinical trials.
• Broad experience and knowledge in clinical operations development.
• Experience supervising and developing direct reports.
• Experience preferred in hosting a Regulatory audit, particularly as it pertains to the eTMF.
• Strong communication skills with the ability to create clear directives.
• Excellent verbal, written, and interpersonal skills.
• Extensive knowledge and understanding of FDA, EMEA, ICH, GCPs governing the maintenance of clinical eTMF.
• Ability to participate in and support cross-functional strategic initiatives.

Working Conditions and Physical Requirements
• 100% on-site work at corporate headquarters in San Diego, CA
• Occasional travel to meetings and conferences as required
• Occasional evening and weekend work will be required
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 368SW.

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.