Sara Penchev
- Role
- Director of Clinical Operations at Biomimetix
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
Experience
Director of Clinical Operations
Nov 2015 — Present · Denver, CO
Manage trial operations for a small biopharmaceutical company, study start up through close out. • Management and coordination of hiring/oversight of team. • Development of company training tools and guidelines, SOPs and study templates. • Development of Case Report Forms, implementation of EDC. • Development of Informed Consent Forms and review and modifications to study protocol. • Review of monitoring reports and communications. • Vendor Management • Contract and Budget Negotiations • Create and maintain Trial Master File. • Ensure compliance with SOPs, ICH/GCP, and all applicable local laws and federal regulations. • General oversight of operations for sponsor.
Education
Indiana University of Pennsylvania
Bachelor of Science (BS), Biology, Chemistry
2003 — 2007
Indiana University of Pennsylvania
BS, Biology
2003 — 2007
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