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Sr. Clinical Operations Program Manager V
Ref No.: 18-13408
Location: Cambridge, Massachusetts
Start Date / End Date: 10/29/2018 to 04/29/2019
Senior Clinical Operations Program Leader - Late Stage Gastroenterology - Boston, MA
Job Description
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future Join us as Senior Clinical Operations Program Leader – Late Stage Gastroenterology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Clinical Operations Program Leader – Late Stage Gastroenterology, you will be empowered to oversee a robust portfolio of clinical programs and their clinical studies and collaborate with our strategic partners.
• 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.
• 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
• 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
• Requires approximately 10-20 % travel, including overnight and international travel to other sites, strategic partners, and therapeutic area required travel.