Clinical Trial Manager in South San Francisco, CA at Apex Life Sciences

Date Posted: 10/12/2018

Job Snapshot

Job Description


Summary:

The Clinical Trial Manager (CTM) will be responsible for the operational management and oversight of clinical trials within a clinical development program. The CTM will also provide oversight of the CRO and other third party vendors on assigned study. 

  Responsibilities: 

  • Manage and oversee performance of CROs and third party vendors.
  • Identify, select, and monitor performance of investigational sites for clinical studies
  • Develop and maintain good working relationships with investigators and study staff
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits
  • Investigate queries, monitor discrepancies
  • Manage investigational product (IP) accountability and reconciliation process
  • Negotiate and manage the budget and payments for investigative sites, if applicable
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents

 Qualifications: 

  • Bachelor’s degree or equivalent with 5+ years of experience in the pharmaceutical/biotechnology industry 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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