Mgr Biopharma Clinical Operations

Biopharma Clinical Operations Manager

The Biopharma Clinical Operations Manager oversees the operational excellence of biopharma clinical studies and manages a team of clinical project coordinators in the Biopharma business unit. The role includes supervising a team of clinical project coordinators within the Biopharma Clinical Operations team, acting as a liaison with the Myriad clinical research team and external clinical study site monitor consultants, creating and maintaining standard operating procedures to ensure high quality clinical trial documentation and sample processing data, performing responsibilities of clinical project coordinator as needed, supporting the quality department in managing regulatory audits, maintaining the Patient Report Identification process, deploying improved operational workflows, collaborating with the Biopharma Business Development team, managing and distributing clinical study sample forecasts, maintaining clinical study design, description and sample testing timeline tracker, and developing and communicating formal documentation to partners when quality issues occur related to Biopharma operations.

Qualifications include a Bachelors degree in a scientific discipline preferred; advanced degree preferred, 5+ years of clinical operations experience, 1-2 years supervising a team of direct reports preferred, knowledge of clinical study design, experience in molecular diagnostics, pharmaceutical, medical device, or CRO setting, strong problem-solving skills, excellent organizational, time management, and project management skills, excellent oral and written communication skills, and some travel may be required 5-10%.