clinical operations in cambridge

posted
job type
contract
salary
US$ 100 per hour
apply now

job details

posted
location
cambridge, massachusetts
job category
Biotechnology & Pharmaceutical
job type
contract
salary
US$ 100 per hour
reference number
25412
apply now

job description

Job Title: Senior Clinical Operations Program Leader - Late Stage Gastroenterology

Position Description

  • You will provide operational expertise and strategic input to the development of Clinical Development Plans.
  • You will develop and lead the operational strategy on assigned programs in close collaboration with our strategic partner.
  • You will represent Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
  • You will provide sponsor's oversight of our strategic partner, program-level direction and support to the clinical study manager(s) responsible for the execution of your studies.

Position Responsibilities

  • Translate the Clinical Research Plan into an optimal operational plan
  • Plan and oversee the overall execution of the assigned clinical program(s) to meet necessary quality, budget and timelines,
  • Responsible for program budget planning and accountable for external spend related to program execution.
  • Communicate program status, cost and issues to ensure timely decision-making by senior management
  • Responsible for operational risk management strategy in collaboration with Strategic Partners
  • Review and provide expert clinical operations input into clinical documents such as Investigator Brochures,
  • Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports
  • Ensure adequate clinical operations resources are assigned to programs
  • Support functional strategic initiatives and process improvement

Position Requirements

  • Bachelor's Degree or international equivalent required, Life Sciences preferred
  • Advanced degree is highly desirable.
  • Experience leading multiple late stage clinical trials
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
  • Demonstrated excellence in project/program management and matrix leadership
  • Fluent business English (oral and written)
  • 7+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management.
  • Experience must include Phase 2 and 3 studies and global/international studies or programs.
  • Experience in more than one therapeutic area
  • TRAVEL REQUIREMENTS:

    • Requires approximately 10-20 % travel, including overnight and international travel to other Company sites, strategic partners, and therapeutic area required travel.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.