Quality Recruiting. Established Experts.

Senior Manager, Clinical Affairs

Reference Number: 2842
Location: NYC

Our client is a clinical stage biopharmaceutical company developing novel oncology therapeutics.  They have asked us to assist them in their search for a Senior Manager, Clinical Affairs.

The Senior Manager, Clinical Affairs independently manages the conduct of several Phase II clinical trials in multiple oncology indications.  The incumbent will oversee assigned responsibilities to ensure project deliverables are met in accordance with the departmental goals and objectives.  This position assists with special projects as assigned and provides overall support for the clinical programs, along with the Program Director.

Major tasks and responsibilities will include:

  • Manages the interaction of appropriate departments and staff to support and maintain the clinical investigations.
  • Directs management and oversight of CRO’s.
  • Manages the conduct of assigned clinical investigations and activities associated with it.
  • Responsible for conducting and participating in clinical team meetings (internal and external).
  • Prepares and maintains study budgets, timelines, and project plans.
  • Assists with the management of the co-monitoring of assigned clinical investigations and coordinates/participates in the co-monitoring of assigned clinical investigations as needed.
  • Oversees the Quality Control review of clinical trial patient databases and clinical files.
  • Supervises training programs to assure consistency and compliance in monitoring of clinical investigations.
  • Maintains knowledge of U.S. and foreign regulations, guidelines, policies and practices for conducting global clinical investigations.
  • Prepares status reports for assigned clinical investigations.
  • Assists in drug usage projections and tracking for assigned clinical investigations as requested.
  • Participates in the initiation and development of the company’s Quality Management System to assure compliance with corporate policies, good clinical practice procedures (GCP’s), or regulations of governmental agencies.
  • Develops and reviews study protocols, case report forms and informed consent documents.
  • Participates in internal/external vendor and site audits.
  • Reviews and participates in finalizing and obtaining approval of final study reports.
  • Reviews tables and listing to support final study report.
  • Contributes to the selection process of new hires, including reviewing candidate’s credentials, interviewing candidates, and making hiring recommendations.
  • May assist with preparation and execution of Investigator Meetings.
  • Assists with preparation of department budgets, timelines, and project plans.

We seek candidates with the following qualifications:

  • An advanced degree (MS, MPH, or MBA) is preferred.  A minimum undergraduate degree in Nursing (RN or BSN), Life Sciences (BA or BS), Pharmacy or Medicine is required.
  • 5-10 years of experience of progressively increasing clinical research experience within the pharmaceutical industry.
  • Experience in oncology indications required.
  • Ability to resolve and make judgments regarding administrative, scientific and/or clinical problems with minimal supervision.
  • Experience in drug development, especially FDA regulations and ICH/GCP guidelines.
  • Must have experience in vendor management, specifically in CRO oversight and management, EDC, IVRS and central laboratory and bioanalytical laboratory management.
  • Experience in IND/NDA/BLA submissions.
  • Clinical monitoring and co-monitoring experience preferred.
  • Ability to identify and resolve problems in a timely manner; gather and analyze information skillfully.
  • Ability to communicate clearly and to deliver oral presentations and write in a clear, focused, and concise manner.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2842. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.