Sadia Iffate
Global Lead Clinical Data Manager @Sarepta Therapeutics
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WORK HISTORY
Global Lead Clinical Data Manager @Sarepta Therapeutics
Coordinate and manage project-level activities for assigned clinical programs and studies, overseeing internal data management (DM) teams, CRO partners, and external vendors, to ensure the timely delivery of high-quality data and compliance with project timelines and specifications.• Collaborate closely with Biometrics, ClinOps, Medical, PV, and Regulatory teams to meet project timelines and deliverables related to clinical data and systems.• Lead and oversee the design of Electronic Data Capture (EDC) systems including review of Database Function Specs & SDS/ALS, eCRFs, DVS/Edit Checks, Data Management Plan (DMP), eCCGs, and conduct EDC user acceptance testing (UAT), ensuring compliance with protocol requirements.• Manage or oversee directly, or through DM team members, database soft/final lock activities for assigned programs, to ensure high quality data with proper documentation and inspection readiness for assigned programs and studies.• Lead or assist with critical data management tasks such as SAE reconciliation, external data reconciliation, patient profiles, and cross-functional data reviews, to ensure the quality and integrity of clinical data.• Lead and support database updates and migrations, including UAT activities, to ensure alignment with protocol amendments and database functionality changes in compliance with regulatory standards.• Contribute to the development, review, and implementation of Standard Operating Procedures (SOPs), and cross-functional standards, ensuring alignment with industry best practices and regulatory requirements.• Review and contribute to clinical documents, including protocols, protocol amendments, DSURs, IBs, and yearly updates to the regulatory authorities.• Provide coaching and mentoring of other DM staff, DM related guidance and training to CROs, vendors, investigators, and clinical sites, as applicable. • Ensure the eTMF is set up and maintained appropriately throughout the duration of the trial.
EDUCATION
The George Washington University School of Medicine and Health Sciences
Masters of Health Science, Clinical Research Administration
University of Massachusetts Lowell
Bachelor of Science, Chemistry
Boston College
Clinical Research Certification
SKILLS
ABOUT SADIA IFFATE
I\'m currently working as a Global Lead Clinical Data Manager for a Bio pharmaceutical company. I have 8+ years of experience in data management for Phase trials related to Cardiovascular, Oncology, Chronic Kidney Disease, and Gene Therapy. My specialties include ensuring robust data quality and accuracy, protecting data integrity, meticulous design of the data collection tools, developing and executing database testing plan and identifying new ways to improve existing processes. I love the challenge of being told \"No\" and turning it to a \"Yes\". While I enjoy every aspect of my job, I have discovered that nothing satisfies me more than meeting new faces, developing new relationships, solving problems, and contributing to the growth of our organization.Oh, I am also a city dweller who love to travel the world and find new adventures along the way.
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