Biotech Contract Clinical Project Manager - All PHASES - ALL THERAPEUTIC AREAS - ALL REMOTE

Precision Life Sciences - Cambridge, MA

Precision Life Sciences is working with various clients in the biotechnology / life science industry that is seeking contract and permanent Clinical Project Managers (all phases, all therapeutic areas, all remote) to join their clinical teams. This is an excellent opportunity for someone with strong organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision. In addition, the successful candidate must have good judgment, be flexible when different tasks arise and be detailed oriented.

Responsibilities

  • Work with the clinical team to support design, development, execution, and delivery of the clinical study in accordance with the clinical development plan/strategy and timelines.
  • Collaborate closely with the Sr. Director of Clinical Operations, working on execution and oversight of clinical trials.
  • Lead in the oversight of CRO activities and other clinical vendors to ensure study quality meets regulatory requirements.
  • Manage multiple vendors to ensure quality operations.
  • Support the Sr. Director of Clinical Operations in reviewing and approving regulatory documents and activating clinical sites.
  • Manage escalation of study-related issues and communicate as appropriate, with leadership and other functions.
  • Anticipate potential study issues and prepare contingency plans with minimal oversight.
  • Collaborate with the cross-functional teams on clinical activities (drug supply, resolution of data queries, etc.) and on selection and management of clinical vendors.
  • Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities.

Qualifications

  • Work with the clinical team to support design, development, execution, and delivery of the clinical study in accordance with the clinical development plan/strategy and timelines.
  • Collaborate closely with the Sr. Director of Clinical Operations, working on execution and oversight of clinical trials.
  • Lead in the oversight of CRO activities and other clinical vendors to ensure study quality meets regulatory requirements.
  • Manage multiple vendors to ensure quality operations.
  • Support the Sr. Director of Clinical Operations in reviewing and approving regulatory documents and activating clinical sites.
  • Manage escalation of study-related issues and communicate as appropriate, with leadership and other functions.
  • Anticipate potential study issues and prepare contingency plans with minimal oversight.
  • Collaborate with the cross-functional teams on clinical activities (drug supply, resolution of data queries, etc.) and on selection and management of clinical vendors.
  • Maintain knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities.
  • ASAP Start


Posted On: Wednesday, July 20, 2022



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