Clinical Project Manager/Senior Clinical Project Manager

Imara

  • Boston, MA
  • Permanent
  • Full-time
  • 2 months ago
  • Apply easily
Can be hired at Clinical Project Manager or Senior Clinical Project Manager level.

POSITION SUMMARY
The Clinical Project Manager will be responsible for the day-to-day operations of IMARA clinical study(ies) from concept through reporting, including inspection readiness and regulatory submission.
Reporting to the VP, Clinical Operations, the Clinical Project Manager will oversee some or all elements of clinical studies with oversight. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical. The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Participates in the internal cross-functional study team(s)
  • Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
  • Manages external vendors, including CROs, central laboratories, and other external service providers, as necessary, from study start-up through final clinical study report
  • Assists in the preparation and review of the protocol, informed consent form, case report forms and associated completion guidelines, and other study documents
  • Manages study timelines, budgets, and quality metrics in accordance with corporate objectives and goals
  • Participates in study feasibility activities
  • Oversee study activities such as: selection of investigators, study start-up activities including site initiation and study monitoring activities
  • Participate in the preparation and negotiation of clinical site and assigned CRO budgets and track variances
  • Project and track study enrollment, deviations, data entry and drug supply
  • Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Develops and maintains relationships with investigators and site personnel to support clinical study activities, including subject recruitment, and ensures protocol and regulatory compliance
  • Communicates study trends, issues, mitigation plans, and lessons learned to IMARA management
  • Manages study-related quality metrics
  • Manages multiple initiatives and shifts priorities within a small company environment
  • Provide routine updates to project team on study status/issues
JOB REQUIREMENTS

Education
  • Bachelor’s or Master’s degree in scientific, biological, life sciences, or related field
Experience, Knowledge, Skills and Abilities
  • At least 5 years of clinical trial management experience with at least 3 years at a biopharmaceutical company with direct management experience of vendors and CROs
  • Technical expertise in and/or understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing) with proficiency in clinical trial monitoring at a minimum
  • Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
  • Ability to work independently
  • Experience managing global studies
  • Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR; familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
  • Ability to assess complex issues and identify creative, practical solutions
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
  • Excellent written, oral and presentation communication skills
  • Proficiency in Microsoft Project and/or other project management software and tools and Microsoft Office (Excel, Word, Outlook, PowerPoint)
  • Experience in all phases of clinical drug development
  • Experience with clinical studies in rare diseases and/or hematology (preferred)
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