Senior Clinical Operations Program Leader: Gastroenterology
A bio-pharmaceutical corporation situated in Massachusetts is seeking to hire a Senior Clinical Operations Program Leader for a 6-month contract. This contractor will be part of a patient-focused company where you will be a vital contributor to the team's inspiring, bold mission.
The Sr. Clinical Operations Program Leader will be responsible for: 1) translating the Clinical Research Plan into an optimal operational plan. 2) Plan and oversee the overall execution of the assigned clinical program(s) to meet necessary quality, budget and timelines. 3) Program budget planning and accountable for external spend related to program execution. 4) Operational risk management strategy in collaboration with Strategic Partners. 5) 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 and clinical study reports.
Location: Cambridge, Massachusetts
Duration: 6-month contract
Compensation: $100-109 per hour
- Education: Bachelor's Degree or international equivalent required, Life Sciences preferred; Advanced degree is highly desirable.
- 7+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management.
- Must have experience must include Phase 2 and 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area is required.
- Requires approximately 10-20 % travel, including overnight and international travel to other sites, strategic partners, and therapeutic area required travel.
Sthree US is acting as an Employment Business in relation to this vacancy.