Director, Clinical Operations


Full time

Framingham, MA

Reporting to the SVP, Operations & General Counsel, the Director of Clinical Operations contributes to the clinical operations of BERG studies while working collaboratively with the CROs, third-party vendors, site investigators and research staff contracted by BERG. Oversees operational aspects of assigned clinical studies worldwide and ensures effective cross-functional teamwork among project team members both internal and external services.

Responsibilities

  • Develop and manage project schedule and scope to ensure both remain on track; implement and follow approved procedures for any deviations
  • Develop spreadsheets and other tools for tracking and managing clinical budgets and timelines
  • Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to industry standards and BERG requirements
  • Prepare and manage protocol amendments and other study documents
  • Ensure that all staff allocated to the assigned project(s) adheres to professional standards and SOPs
  • Prepare and actively participate as the operational lead in internal Project Review meetings. Depending on the size and scope of the project, this job duty may be performed in collaboration with a senior member of the Clinical Operations team
  • Create required project plans; implement and monitor progress against project plans and revise as necessary; review clinical protocols, CRF’s, study reports, informed consent forms and other study documents as needed
  • Ensure that clinical research is cost-effective by analyzing internal and external costs, resource utilization and performance data
  • Negotiate & establish contracts and budgets with external clinical sites and vendors
  • Develop training programs for internal and external resources
  • Ensure work is performed in accordance with industry standards, federal and state regulations, accreditation standards and Berg Pharma mission and core values
  • Ensure adherence to protocols and compliance with GCP, ICH, GLP, GMP, and regulatory guidelines
  • Participate in global research activities such as creating IBs, INDs, IMPDs, DSURs, and OUS study document filing
  • Audits of study vendors
  • Participate in quality and/or process improvement activities
  • Comply with all safety and work rules, policies, and procedures
  • Perform internal audits of work on a regular basis; initiates and implements corrective actions with results
  • Prepare reports, documents, statistical surveys, and other such data as needed
  • Other related duties as assigned

Qualifications

  • Requires a BS degree in a scientific discipline with 8+ years of clinical research experience in the pharmaceutical industry and/or CRO, (or equivalent) with a strong preference for experience in oncology.
  • Excellent MS Office applications skills, especially well-versed in the development and use of Excel spreadsheets
  • Strong understanding of regulatory requirements
  • Ability to communicate effectively with physicians, fellow employees, patients, guests, contractors, and vendors