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Allogene Therapeutics · 2 weeks ago

Clinical Trial Manager (Contract)

United States

Full-time, Contract

Remote

Mid Level

3+ years exp

Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T cell products for cancer and autoimmune diseases. The Clinical Trial Manager will oversee clinical trials, ensuring compliance, data quality, and effective communication across teams, while managing study deliverables and operational issues.

BiotechnologyHealth DiagnosticsOncologyPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Clinical trial managementICH/GCP knowledgeVendor managementOncology therapeutic developmentProject management skillsTeam-building skillsCommunicationOrganizational skillsProblem solvingConflict resolutionLeadership skills

Required

Bachelor's degree or equivalent combination of education/experience in science or health-related field with at least 3 years of clinical trial management experience in a Pharmaceutical/Biotech organization

Clinical trial management experience as a contractor or employee of an industry sponsor

Vendor management

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