Clinical Project Manager

Boston, MA

Responsibilities

 

  • Financial management of a study/program, and develops and oversees study timelines.
  • Represents and guides the study team to design, develop, implement and deliver the clinical study in accordance with the clinical development plan/strategy and timelines
  • Global clinical trial experience and the capacity to lead/manage more than one clinical trial
  • Writes/ reviews/ adds to clinical study documents
  • Reviews and approves study related plans generated by Clinical CROs and vendors
  • Provides input as the subject matter expert for the study during regulatory inspections
  • Executes the clinical study in accordance with the project clinical development strategy and timelines
  • Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines
  • Responsible for oversight of identification and selection of investigator sites
  • Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments
  • Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team
  • Collaborates with the cross functional team on selection and management of clinical vendors
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
  • Trains and manages CRO and other clinical vendor activities to ensure the quality meets company and regulatory requirements
  • Monitors the status of clinical data collection of assigned clinical studies
  • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
  • Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required
  • Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
  • Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact
  • Responsible for the availability and tracking all relevant study information/ study metrics

 

Requirements

 

  • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required
  • 6+ years’ experience working in clinical operations within a pharmaceutical company or CRO or similar organization
  • Minimum of 3 years’ experience working as a Clinical Research Associate (CRA) and/or monitoring experience
  • Must be able to manage complex global trials and/or multiple clinical trials
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Strong knowledge of applicable computer and project management software packages
  • Familiarity with financial budgeting and forecasting or reporting

 

 

 

 

Note: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, we will keep your resume on file for future opportunities and may contact you for further discussion.

Date Posted 6/25/2020
Salary $75.00/hr






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