Clinical Trial Manager, Clinical Operations

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About Allogene Therapeutics, Inc:

Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.

At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

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.

Responsibilities include, but are not limited to:

• Manages 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.).
• Ensures clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation; reviews monitoring reports to ensure quality and resolution of site-related issues. Includes interfacing with QA for CAPA documentation and resolution.
• Manages the study submission to IRB/ECs in coordination with CRO, as appropriate.
• Leads selection activities for external vendors and is responsible for the management/oversight of external vendors including: the development vendor specifications; review vendor reports, budgets, and metrics;
• Provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
• Works with Clinical Operations senior management and finance to manage the study budget. And ensures it aligns with department financial goals; reviews and approves clinical invoices against approved budget. Coordinates review of updates or revisions with key cross-functional partners, as necessary.
• Conducts the internal review of investigator contracts and payments, as necessary.
• Prepares and presents project debriefings to Clinical Operations management.
• Uses operational and therapeutic expertise to optimize trial design and execution, and works with the study team to strategize on clinical trial execution.
• Works with the CRO to select and approve sites and manages start-up processes toward activating sites; develops relationships with investigators and site staff.
• Interfaces with cross-functional teams as Clinical Operations study lead (e.g. Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Works cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
• Provides study-related guidance and leadership to internal and external partners, as appropriate.
• Other duties as assigned

Position Requirements & Experience:

• Bachelor's degree or equivalent combination of education/experience in science or health-related field.
• Minimum of 6 years of clinical trial management experience in a Pharmaceutical/Biotech organization.
• Global, registrational study experience.
• Oncology experience, with T-cell immunotherapy experience strongly preferred.
• 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.

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.

Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.

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