CenterWatch

29 days old

Senior Study Manager

Maven Talent
Troy Hills, New Jersey

Summary:

Emerging bio-pharmaceutical company is seeking a Senior Study Manager to manage assigned clinical trials.

Responsibilities:

  • Manage multiple projects and lead multiple study teams.
  • Monitor study timelines to ensure that all deliverables are met.
  • Lead study team meetings to review study status using powerpoint presentations and WebEx technology.
  • Attend weekly teleconference with CRO.
  • Identify and select high-quality clinical vendors in conjunction with the appropriate team members by interviewing and assessing a vendor’s skill set.
  • Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined.
  • Manage and effect oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements.
  • Collaborate with team on key study documents: protocols, case report forms, informed consent documents, study management plans and final clinical study reports.
  • Communicate with Principle Investigator, Study Coordinator and CRO to proactively recognize and resolve issues.

Requirements:

  • Bachelors Degree Required
  • 10+ years of experience managing global clinical trials
  • Strong organizational and planning skills
  • Knowledge of regulatory requirements and ICH-GCP guidelines
  • Knowledge of risk-based monitoring concepts
  • Excellent verbal and written communication skills

Categories

Posted: 2018-11-15 Expires: 2018-12-15

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Senior Study Manager

Maven Talent
Troy Hills, New Jersey

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