Clinical Study Manger

Job type:
Start date:
12 months
Real Staffing
Published at:
flag_no USA
Project ID:

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The Clinical Study Manager is responsible for the overall management of designated clinical trials and collaborates cross-functionally to ensure corporate goals and objectives are met.

Responsibilities include but not limited to:
  • Lead clinical team to achieve seamless management and execution of clinical trials from initiation through regulatory submissions. Assist in strategic planning including monitoring, auditing, and data management
  • Manages and maintains the relationships with the expert outsourced consultants or in-house Clinical Research Associates
  • Projects and coordinates study supply and packaging requirements. Coordinates site training and protocol implementation for partnered programs
  • Manages out-sourced activities for clinical studies, such as CROs and bio-analytical labs
  • Monitors sites to ensure adherence to timelines and protocol requirements
  • Identifies program/resource gaps and proposes solutions. Provides weekly enrollment and program updates to senior management
  • May mentor and develop junior clinical operations staff

Education Requirements:

Bachelors/Masters degree in a scientific discipline. A minimum of 6 years Pharmaceutical or Medical Device experience with at least 2 years managing CROs is required. Candidates with 4+ years experience managing global clinical trials is highly desirable.

Must have demonstrated problem-solving abilities, strong organizational skills, and understanding of ICH / GCP required. Excellent written and verbal communication skills are important for this position. Must be a demonstrated self-starter and team player with strong interpersonal skills.

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