Clinical Trial Manager
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. About the role: The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required.
Requirements
- Bachelor's degree or equivalent combination of education/experience in science or health-related field with clinical trial management experience in a Pharmaceutical/Biotech organization
- Clinical trial management work experience from an industry sponsor
- Prior clinical trial experience in oncology therapeutic development
- Robust understanding of ICH/GCP, and knowledge of regulatory requirements
- Strong clinical study/project management skills
- Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills
- Candidates must be authorized to work in the U.S.
Nice To Haves
- Vendor management experience
- Multi-regional study management experience is preferred
Responsibilities
- Manage all clinical aspects of study under oversight of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics
- Study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.)
- Plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.)
- Interface with cross-functional teams as Clinical Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff).
- Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial
- May oversee clinical trial execution in one or more regions within a global clinical trial
- Review protocol and amendment development, Informed Consent Forms, clinical trial-related training, and Site Study Tools
- Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF
- Partner with Clinical Quality Assurance to follow through on corrective and preventative actions (CAPA) identified during internal and external audits
- Vendor oversight: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics
- Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
- Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary
- Prepare and present project debriefings to Clinical Operations management
- Provide study-related guidance and leadership to internal and external partners, as appropriate
Benefits
- We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
