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. Supervises a team of clinical project coordinators within the Biopharma Clinical Operations team. Liaison with the Myriad clinical research team and external clinical study site monitor consultants to support diagnostic site monitoring activities and audits. Create and maintain standard operating procedures to ensure high quality clinical trial documentation and sample processing data is established from triage through sample reporting. Train and develop team members to meet established internal and external quality standards (e.g., GCP). Perform responsibilities of clinical project coordinator as needed when team capacity is constrained. Support the quality department in managing regulatory audits as applicable to Biopharma Clinical Operations. Responsible for maintaining the Patient Report Identification process and ensuring correct patient report templates and intended uses are correctly identified and implemented for each clinical study. Deploy improved operational workflows for the Biopharma Clinical Operations team and enable frequent tracking and reporting of study metrics to ensure consistent process improvement and efficiencies. Collaborate with the Biopharma Business Development team to ensure clinical study contracts contain internal operational requirements. Collaborate across internal departments to improve cross functional operation efficiencies and to resolve issues which impact pharma partner testing or biopharma operations. Manage and distribute clinical study sample forecasts to support revenue projection requests. Maintain clinical study design, description, and sample testing timeline tracker. Develop and communicate formal documentation (e.g., memos) to partners when quality issues occur related to Biopharma operations.

Qualifications : Bachelor's degree in a scientific discipline preferred; advanced degree preferred. 5+ years of clinical operations experience as a clinical trial manager, clinical project coordinator, clinical research associate, or equivalent role. 1-2 years supervising a team of direct reports preferred. Knowledge of clinical study design with experience in clinical monitoring procedures (SOPs) and knowledge of GCP guidelines preferred. Experience in molecular diagnostics, pharmaceutical, medical device, or CRO setting with experience supporting research studies from start to finish. Strong problem-solving skills, ability to identify and creatively resolve complex clinical operational issues. Excellent organizational, time management, and project management skills. Excellent oral and written communication skills, demonstrated by the ability to present clear instruction / direction and influence at higher levels within the organization. Some travel may be required. 5-10%.