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Clinical Trial Project / Study Manager
NPAworldwide Recruitment Network
NPAworldwide Recruitment Network
 
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Job Location: Norwalk, CT
JOB DESCRIPTION

Job #: 19205
Title: Clinical Trial Project / Study Manager
Job Location: Norwalk, Connecticut - United States
Employment Type:
Salary: $130,000.00 - $150,000.00 - US Dollars - Yearly
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?

The Clinical Trial Project Study Manager will be responsible for all aspects of study conduct and CRO oversight. The CTPM will be the primary point of contact for clinical study project management, communications, and decisions for the clinical trial.


JOB DESCRIPTION

  • Clinical Trial Project / Study Manager
  • Manage all clinical aspects of the study, including responsibility for oversight of study execution, develop and manage comprehensive study timelines and metrics; management/oversight of external vendor deliverables reports and budgets.
  • Study budget management and oversight of vendor and site payments. Liaise with MMRFs finance group on budget expense projections and payment reconciliation. Review and approve clinical invoices against approved budgets.
  • Tracking of all CDA, MSA, Agreements and other legal documentation as required for new and returning sponsors, vendors and suppliers.
  • Ensures audit-ready condition of clinical trial documentation including central clinical files.
  • 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).
  • Write and review study protocols, informed consents and amendments.
  • Ensures SAEs /SUSARs are managed and reported according to the study safety plan
  • Description of ideal candidate:


    • 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.
    • Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required.
    • 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.
    • Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
    • Strong 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.
    • Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
    • Ability to identify and manage or escalate risks.
    • Ability to manage complex protocols within a matrix environment.


QUALIFICATIONS

  • Clinical Trial Project / Study Manager
  • Bachelors Degree (BA, BS) in scientific or health care discipline preferred.
  • 5 + years of Pharmaceutical, Biotech or Contract Research Organization preferred
  • 5+ years of Hematology Oncology clinical research experience a plus
  • Ability to travel as necessary (approximately 5 to 10%)

Education:
University - Bachelor`s Degree/3-4 Year Degree




How to Apply:


 
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