Senior Clinical Operations/Program Manager

30+ years of Clinical Research experience across multiple therapeutic areas for the biotech and pharma industries in Phase I-III trials. Expertise includes trial management, site management, vendor/CRO selection and management, monitoring in accordance with GCP/ICH, protocol and other requirements, patient recruitment, and training/mentoring direct reports and staff. Broad experience in Operational leadership of Multiple Global clinical trials across many therapeutic areas such as Oncology, Psychiatry, Arthritis, Metabolism, GI/GU, and Cardiovascular diseases in both early and late-stage development.

Relevant Therapeutic Areas

  • Oncology
  • Psychiatry
  • Arthritis
  • Metabolism
  • GI/GU
  • Cardiovascular

Product Technologies

  • Small Molecules/Drugs
  • Solid Tumors

Recent Titles

  • Senior Clinical Project Manager/Clinical Advisor
  • Senior Director, Clinical Study Team Lead, Oncology
  • Executive Director, Clinical Operations Group Lead

Location

  • Connecticut
  • Open to remote and travel

Relevant Companies

  • Pfizer
  • National Institute of Health

Skills & Accomplishments

  • Working hands-on clinical trial oversight in COVID-19 trials with NIH.
  • Working in oncology since 2017 in a variety of different indications (Prostate, Colon).
  • Successful site activation, recruitment remediation, data management remediation, operational delivery, close-outs, and vendor management for multiple successful studies.