Clinical Study Manager

Clinical Study Manager Opening Available with a Biotech Company!

This position is responsible for the planning and oversight of clinical studies and GCP related activities for several programs simultaneously, providing leadership and consultation within the department, across divisions, and to external clients. Assignments include protocol development, development team leadership, SOP development, and supervision of indirect reports.

Essential Duties & Responsibilities

• Independently perform or guide clinical activities on programs consisting of multiple studies running simultaneously.
• Serve as a direct study manager on a portion of studies within a program, fulfilling all associated duties.
• Responsible for managing the conduct of single and multi-center studies and study activities such as study design, protocol preparation, investigator selection, investigator meeting, budget and contract preparation, negotiate final budgets with investigators and/or institutions, and development of monitoring/communication/enrollment plans.
• Review and approve monitoring visit reports, regulatory documents, and other key study records.
• Develop systems for the tracking of projects, including site information, IRB/IEC information, study progress, subject recruitment activities, and other clinical trial materials, as needed.
• Contribute to authorship of study protocol(s) and coordination of clinical activities across all assigned studies.
• Oversee clinical processes to ensure timelines are met.
• Identify and oversee resource requirements with team and Sr. Director Clinical Operations.
• Organize, oversee and implement protocol training and other supportive activities at Investigator meetings.

Position Expertise/Qualifications

• Bachelors scientific/technical discipline,
• Pharmacy, Biological Sciences, Chemistry, or other appropriate

Please apply today if interested!!