Clinical Trial Management Associate (Contract)

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.

Responsibilities include, but are not limited to

• 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

Position Requirements & Experience

• 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.

We offer a chance to work with talented people in a collaborative environment. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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