Michelle Pisko
- Role
- Senior Director Head of Clinical Data Management at Alector
- Location
- Chester Springs, PA, US
- LinkedIn followers
- 500 followers
About Michelle Pisko
My accomplished management career reflects more than 25 years of increasing…
Experience
Senior Director Head of Clinical Data Management
Oct 2021 — Present
Provide visionary leadership to the CDM function. Advocate for standardization, automation, and innovation in Clinical Data Management (CDM) to enhance drug development efficiency-Establish robust CDM processes and SOPs to ensure top-notch data quality and regulatory compliance with FDA, GCP, and ICH guidelines-Lead CoDE (Center of Digital Excellence) to champion new technology and innovative solutions to ensure systematic selection and implementation across the company-Deployed new Generative AI tool as a member of the Generative AI Committee to incorporate AI into CDM tasks and into the broader organization processes-Ensure third-party suppliers, CROs, and internal teams adhere to the highest quality standards-Establish key performance metrics with CROs to guarantee data quality and regulatory compliance-Lead the evaluation, qualification, and selection of vendors and technologies such as EDC or IRT-Utilize scientific knowledge and drug development expertise to anticipate and mitigate data management challenges-Support strategic decision-making involving data management for new and ongoing clinical trials-Encourage productive collaboration between Clinical Data Management and other functions such as Biostatistics, Analytical Programming, Biomarker Operations, Clinical Operations, and Regulatory Affairs-Identify and implement solutions relevant to CDM and other cross-functional partners-Provide strong and inspiring leadership to CDM staff, fostering team engagement, and talent development.
Education
York College of Pennsylvania
BSN, Nursing
York College of Pennsylvania
Master of Business Administration (MBA), Health/Health Care Administration/Management
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