Clinical Trial Management Associate (Contract)

Allogene Therapeutics • South San Francisco, CA

5d

About The Position

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: Allogene Therapeutics is seeking a highly motivated Clinical Trial Management Associate to be responsible for the coordination of activities associated with clinical trial startup and maintenance under the direction of, or as delegated by a member of the Clinical Operations team. Responsibilities will range from clinical study coordination to data entry projects and general office work. This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.

Requirements

• Minimum requirement of a BA/BS or equivalent degree
• Clinical research experience preferably in cell therapy and/or oncology.
• Knowledge and understanding of ICH/GCP guidelines and FDA requirements for INDs and NDAs
• Flexibility and adaptability within a highly dynamic clinical environment
• Effective interpersonal and communication skills
• Ability to work independently as well as part of a team
• Outstanding organizational skills with the ability to multi-task and prioritize
• Ability to build and maintain successful professional relationships with vendors, other staff and investigators
• Experience with TMF maintenance and management
• Ability to proactively identify potential study issues/risks and recommends/implements solutions
• Candidates must be authorized to work in the U.S.

Responsibilities

• Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, Institutional Review Board (IRB) submissions, enrollment, study maintenance, and close-out
• Conduct study tracking activities (eg sites activation & participant enrollment status, reconciliation activities, filing & archiving)
• Assist the Study Lead with the development, oversight, and/or completion of essential clinical documents including, but not limited to clinical study protocol, informed consent form, training slides and materials
• Contribute to region-specific document development including, but not limited to, the informed consent forms, regional investigator meetings/presentation of materials, the development of regional enrollment initiatives, and planning regional clinical study supplies
• Support the Study Lead in overseeing, managing, and tracking performance of assigned vendors selected for a clinical study which may include acting as a point of contact as delegated by the manager, facilitating review of vendor study specific documents, tracking performance indicators for vendors, creating and maintaining a vendor-specific issues log
• Participate in the review of review monitoring/data reports, protocol deviations to ensure reliable quality data is delivered
• Assist with the oversight and maintenance of the study’s TMF
• Support Clinical Logistics with investigational supply communications and tracking

What This Job Offers

• Career Level: Entry Level
• Number of Employees: 101-250 employees