Senior Clinical Trial Manager
Translational Sciences | South San Francisco, CA | Full Time
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy 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 Twitter and LinkedIn.
The Senior Clinical Trial Manager is responsible for the management of clinical trials from study start-up activities through the clinical study report. This role will drive 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.
- Manages all clinical aspects of study: budget and metrics; operations; study document development and review (study specific plans, eCRF Guidelines, lab manuals, 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 of vendors and CROs; ensures audit-ready condition of clinical trial documentation. Includes interfacing with QA for CAPA documentation and resolution
- Manages the study submission to IRB/ECs in coordination with CRO, as appropriate.
- Works with Assay Leads to select external vendors and is responsible for the management/oversight of external vendors including: the development of 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 Assay Leads 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
- Prepares and presents project debriefings to Clinical Operations management.
- Uses operational expertise to optimize sample management design 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.
- Works cross-functionally with Clinical Operations, Supply Chain, Biometrics, CRO, vendors and Investigators/site staff 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
- Sample management 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 and team-building skills
As an equal opportunity employer, Allogene Inc. 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.