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Clinical Trial Manager in Norwalk, CT at Apex Life Sciences

Date Posted: 12/3/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Norwalk, CT
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/3/2018
  • Job ID:
    918169

Job Description


                               Clinical Trial Manager

Position Overview:  The Clinical Trial Manager will be responsible for all aspects of study conduct and CRO oversight and the primary point of contact for clinical study project management, communications, and decisions for the clinical INDs. Experience and knowledge of end to end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and regulatory components is essential.

Job Responsibilities:

  • Ability to manage complex protocols within a matrix environment.
  • Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required.
  • Demonstrated ability to drive clinical trial activities: i.e. experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, budgeting.
  • Manage all clinical aspects of the study, including responsibility for oversight of study execution, develop and manage comprehensive study timelines and metrics
  • Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Study Management Meetings, site calls etc.). 
  • Study budget management and oversight of vendor and site payments. Review and approve clinical invoices against approved budgets. 
  • Review and sign off on monitoring reports, ensure study issues and action items are addressed and closeout appropriately and in compliance with study management plans.
  • Prepares and/or reviews study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals). 
  • Tracking of all CDA, MSA, Agreements and other legal documentation as required for new and returning sponsors, vendors and suppliers.
  • Ensures SAEs /SUSARs are managed and reported according to the study safety plan.
  • Excellent working knowledge GCP, FDA and ICH Guidelines. Ensures the assigned clinical trials are executed in compliance with FDA and ICH GCP guidelines/regulations and SOPs.


Qualifications:

  • BS or MS preferred in scientific or health care discipline preferred.
  • 8 + years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
  • Hematology oncology Therapeutic Experience preferred.
  • Project Management (CRO/Pharma) required

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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.




918169