Laleh Sinai

Tmf Lead @Alexion Pharmaceuticals, Inc.

Mississauga, ON, CA

Drive TMF portfolio level initiatives (i.e. process change/development) with CRO(s) • Ensure standards of compliance are adhered to across the portfolio and partnerships • Oversight of assigned portfolio TMF related ongoing activities (i.e. TMF QC schedule maintance, TMF storyboard maintenance) • Mentor and provide high-level oversight of junior TMF positions within assigned portfolio • Assist with establishing and maintaining TMF monitoring and reporting • Delivers KPI reports to study team, manages expectations, and tracks ongoing KPI across study team in conjunction with the Clinical Trial Managers and Clinical Project Leads • Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices • Assist with CRO eTMF configuration testing as needed • Assists with and deliver TMF process education efforts • Provides process and planning support the CTM and CPLs for TMF related remediation and process execution as needed • Proactively stay current with best practices and recommends application across portfolio to continuously improve TMF operations processes • Leads projects in support of study or portfolio TMF objectives and attend standing cross functional meetings • Train internal/external study team and departments on TMF related expections, tools, processes, etc.

Ruprecht-Karls-Universität Heidelberg / University of Heidelberg

Master's degree

University of Toronto

Doctor of Philosophy (Ph.D.)