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Allogene Therapeutics logo
Allogene Therapeutics

Allogene Therapeutics is a biotechnology company that is on a mission “to transform the treatment of cancer.” The company has cultivated a high-performance team that is motivat

Clinical Trial Manager

Location

United States

Posted

91 days ago

Salary

$130K - $155K / year

Seniority

Lead

No structured requirement data.

Job Description

Clinical Trial Manager

Allogene Therapeutics

Role Description 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. - 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. Qualifications - Bachelor's degree or equivalent combination of education/experience in science or health-related 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 resolution, leadership and team-building skills. - Candidates must be authorized to work in the U.S. Benefits - Annual performance bonus. - Equity. - Health insurance. - Generous time off (including 2 annual holiday company-wide shutdowns). - Much more.

Job Requirements

  • Bachelor's degree or equivalent combination of education/experience in science or health-related 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 resolution, leadership and team-building skills.
  • Candidates must be authorized to work in the U.S.

Benefits

  • Annual performance bonus.
  • Equity.
  • Health insurance.
  • Generous time off (including 2 annual holiday company-wide shutdowns).
  • Much more.

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