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Manager, Clinical Operations

New Jersey All, NJ

Posted: 02/12/2019 Job Type: Clinical Job Number: JN -022019-23675
  • Oversee in the management of clinical trial activities to ensure compliance with the study protocol and overall clinical study objectives (e.g., review and sponsor oversight of trip reports, etc.)
  • Develop and oversee the management of key study related documentation (e.g., ICF, pharmacy manual, monitoring plan, CRF completion guidelines)
  • Oversee and directly participate in sponsor quality and co-monitoring investigational study sites activities, oversee the management of the CRO and associated vendors to verify that study conduct is in compliance with the protocol, GCPs, ICH and local regulations and company SOPs/WIs and manages the CRO s deliverables in accordance with the study timelines
  • Provides study specific training and education for internal and external project team members, as necessary
  • Responsible for direct oversight and the tracking of study progress and maintaining study status updates (e.g., IRB approvals, regulatory document collection, patient enrollment, SDV status, etc.) and reporting and escalation of issues
  • Direct oversight and responsible for performing in-depth clinical review of study data and other aspects as necessary to ensure data integrity
  • Directly responsible for the creation, management, maintain and QC of the Trial Master File
  • Manages and responsible for the CRO s deliverables in accordance with the study timelines
  • Manages and reports study milestones in CTMS, status updates and alerts project team of potential delays in appropriate clinical systems
  • Supports the clinical team with completion of clinical sections for regulatory filings, e.g. NDA, DSUR
  • Initiates and supports the study team s development and implementation of risk mitigation strategies
  • Provides clinical input into cross-functional activities
  • Manages and reports on the study milestones, status updates, and alerts project team of potential delays
  • Contributes to the ongoing scientific review of the clinical trial data during the course of the trial
  • Identifies and assists in streamlining and standardizing departmental policies/procedures
  • Position requires a minimum of a completed Bachelor s degree, preferably in a health/medical related field or life sciences
  • Minimum of 5 years of Trial Management pharmaceutical/biotechnology industry experience
  • Must have a thorough understanding of clinical study design, CRF design, and project management and familiarity with data handling
  • Must have experience in supervising and managing vendors, especially CROs
  • This individual should possess a thorough understanding of clinical drug development and be proficient in GCP, ICH and the regulatory requirements for clinical trials

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