Senior Clinical Trial Manager (Contract)

Job Description

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 :

The Senior Clinical Trial Manager (Sr. CTM) is responsible for management of clinical trials from study start-up activities through the clinical study report. A Sr. 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.

Responsibilities may include, but are not limited to :

• 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, Safety, CMC, Supply Chain, CQA, CRO, vendors and Investigators / site staff). Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
• May lead cross functional study management team or oversee clinical trial execution in one or more regions within a global clinical trial.
• Use operational and therapeutic expertise to optimize trial design and execution; identify process improvements within and across clinical studies.
• Contribute to 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 in the planning of quality assurance activities and coordinate resolution of audit findings including initiation and follow through on corrective and preventative actions (CAPA)
• Vendor selection and set up (including scope of work development and review), may include Clinical Research Organization (CRO), central lab, imaging, and specialty labs.
• Vendor oversight : effectively communicate expectations to CRO / vendor, ensure appropriate site management, hold CRO / vendor 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.
• Other duties as assigned.

Position Requirements & Experience :

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.