Associate Director, Clinical Trial Management

93475_1707225831
  • $170000 - $190000 per anuum
  • New York
  • Permanent

The base salary range for this position is $170,000 - $190,000.

What you will be Doing

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

  • Coordinate site management activities:
  • Site identification, recruitment, and selection.
  • Regulatory document collection and review.
  • Overall scheduling and management of all site visits.
  • Develop site/monitoring tools and training materials.
  • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
  • Coordinate and oversee daily operations of clinical monitoring team:
  • Set and enforce project timelines with the assigned study team.
  • Coordinate remote review of clinical data within EDC system.
  • Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.
  • Review and approve trip reports and follow-up letters within required timeframe.
  • Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
  • Manage project milestones and proactively address deficiencies

Manage CRA performance:

  • Define and implement functional standards, goals, and expectations with clinical monitoring team.
  • Serve as CRA mentor and perform accompanied field assessment visits as required.
  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
  • Documentation Duties/Responsibilities:
  • Assure that the appropriate SOPs are followed.
  • Ensure all project documentation is appropriately filed per SOPs.
  • Assist PM in preparation of audit responses, as appropriate.

Required Experience

  • Thorough knowledge of clinical research process.
  • Strong communication skills (verbal and written) to express complex ideas.
  • Excellent organizational and interpersonal skills.
  • Ability to manage multiple priorities within various clinical trials.
  • Ability to reason independently and recommend specific solutions in clinical settings.
  • Understanding of basic data processing functions, including electronic data capture.
  • Working knowledge of current ICH GCP guidelines and applicable regulations.
  • Ability to work independently, prioritize and work with a matrix team environment is essential.
  • Prior experience in electronic data capture (EDC) preferred.
  • Able to mentor CRAs and more junior Clinical Trial Managers.
  • BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
  • Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
  • Minimum of 5 years as a successful Lead CRA or Clinical Trial Manager.
Marc Roessle Team Lead

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