Typical Tasks of the RESQ Project Manager

RESQ Project Managers are responsible for the day to day operations of a given clinical study to include the following:

  • Provide input into protocols, case report forms, EDC screens, data management plans, clinical study reports, and regulatory filings.
  • Develop clinical protocols, Investigator's brochures, training material, case report forms, diary cards, clinical project manuals, clinical study reports and other clinical documents in compliance with applicable regulatory requirements, as required by the Sponsor.
  • Design and review informed consent forms in compliance with applicable regulatory requirements, as required by the sponsor.
  • Manage CRAs and provide guidance, as needed.
  • Define project specifications and assist with the evaluation of potential FSPs.
  • Continuously monitor clinical project progress and manage study timelines while intensively managing the schedule’s “critical path.”
  • Report on study progress and identify and expeditiously resolve clinical project problems.
  • Ensure all tasks that contribute to the conduct of the clinical project are completed on time and within budget.
  • Maintain paper and electronic filing and tracking systems.
  • Participate in writing clinical sections for regulatory documents (e.g., BLA or IND).