Senior Clinical Trial Manager


Full time

Framingham, MA

Posted 6 days ago

Reporting to the SVP, Operations & General Counsel, the Sr. Clinical Trial Manager 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 assigned project(s) adheres to professional standards and SOPs
  • Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of 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 a 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