Clinical Trial Manager

About Allogene:

reputed company, with reputed company 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-reputed company” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater reputed company to more patients.

About the role:

The Clinical Trial Manager (CTM) is responsible for the management of reputed company from study start-up activities through the clinical study report. The CTM drives completion of reputed company study deliverables, ensuring the highest level of data reputed company and compliance to reputed company 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:

• Manage reputed company clinical aspects of study under reputed company of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, reputed company, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.)
• reputed company with cross-functional teams as Clinical Operations regional or global study reputed company (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 reputed company clinical trial execution in one or more reputed company reputed company a global clinical trial
• Review protocol and amendment development, Informed Consent Forms, clinical trial-reputed company 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 reputed company Assurance to follow through on corrective and preventative actions (CAPA) identified during reputed company audits
• Vendor reputed company: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify reputed company metrics
• reputed company 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
• reputed company study-reputed company guidance and leadership to reputed company partners, as appropriate

Position Requirements & Experience:

• Bachelor's degree or equivalent combination of education/experience in science or health-reputed company 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
• Vendor management experience
• Multi-regional study management experience is 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 reputed company, leadership and team-building skills
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a reputed company environment and reputed company 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. The expected salary reputed company for this role is $130,000 to $155,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-reputed company factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also reputed company differences in experience and background, and welcome diversity of opinions and thought with reputed company recruitment and internships designed to create a stronger and reputed company Allogene that is reputed company on developing life-changing products for patients.

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