Michele Snyder Email & Phone Number

Clinical operations subject matter expert with extensive experience in leadership, clinical trials management, and vendor management. Known for proven ability to manage all phases of clinical research across multiple therapeutic areas and direct experience in pharmaceutical, medical device, CRO, and biopharmaceutical arenas. Adept at analyzing current procedures and business needs, and leveraging industry knowledge, strategic thinking, and communication skills to implement process improvements that streamline operations, comply with regulatory requirements, and exceed stakeholder expectations. History of success leading, coaching, and mentoring high performing global teams that consistently achieve targeted goals.

Paris, France, Fr

Tampa, Florida, Us

Maple Grove, Mn, Us

Retained as a clinical operations expert and charged with executing and managing clinical studies in epilepsy. Added significant value as a subject matter expert in new drug development. The company recently expanded into in-licensing and new drug development to support their strategic growth plans. Active member of SOP Committee with responsibility of creating / revising SOPs to ensure compliance. Contributing Clinical Quality Management team member; completed a GAP analysis for Clinical Development and in the process of rolling out program to address the GAP analysis findings.

Integral member of cross-discipline management team. Built Clinical Operations Department and effectively managed internal staff, outside vendors for clinical trial support, and physician relationships. Contributed to development and implementation of departmental policies, SOPs, and procedures. Ensured clinical operation goals were completed in accordance with relevant corporate SOPs, FDA, Medical Device Directive, 93/42/EEC Annexes VIII and X, GCP/ICH, ISO 14155 Part 1 and Part 2, Code of Federal Regulations, Declaration of Helsinki and foreign regulations. Managed CEC and DSMBs.