Sr. Clinical Operations Program Manager

Highly Competitive
  1. Permanent
  2. Program Manager / Director
  3. United States
Cambridge, Massachusetts
Posting date: 05 Mar 2019

ProClinical is partnering with a leading global pharmaceutical company to advertise a vacancy for a Senior Clinical Operations Program Leader position. The organization pride themselves on its superb pipeline of products that include treatments for diabetes, cancer, and asthma. They are currently looking to recruit an applicant to work in their Massachusetts office. The company offers an excellent rate of pay and have a strong reputation as an excellent company to work for.

As a Senior Clinical Operations Program Leader - Late Stage Gastroenterology, you will oversee a robust portfolio of clinical programs and their clinical studies and collaborate with our strategic partners.

Job Responsibilities:

  • Providing operational expertise and strategic input to the development of Clinical Development Plans.
  • Developing and leading the operational strategy on assigned programs in close collaboration with the company's strategic partner.
  • Representing Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
  • Providing sponsor oversight to strategic partners, program-level directions, and support to the clinical study managers responsible for the execution of studies.
  • Translating the Clinical Research Plan into an optimal operational plan.
  • Planning and overseeing the overall execution of the assigned clinical program(s) to meet necessary quality, budget, and timelines.
  • Planning program budgets and taking accountability for external spending related to program execution.
  • Communicating program status, costs, and issues to ensure timely decision-making by senior management.
  • Overseeing operational risk management strategy in collaboration with Strategic Partners.
  • Reviewing and providing expert clinical operations input into clinical documents, such as Investigator Brochures.
  • Participating in Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, and clinical study reports.
  • Ensuring adequate clinical operations resources are assigned to programs.
  • Supporting functional strategic initiatives and process improvement.

Skills and Requirements:

  • A Bachelor's Degree, preferably in a Life Sciences Field, or an international equivalent.
  • An advanced degree is highly desirable.
  • Demonstrable experience in 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.
  • Demonstrable excellence in project/program management and matrix leadership
  • At least seven years pf experience in pharmaceutical industry and/or clinical research organization, including at least four years of clinical study management.
  • Experience must include Phase 2 and 3 studies and global/international studies or programs.
  • Experience in more than one therapeutic area.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Kevin Cassinni at +1 215 531 5288 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.