Sadia Iffate

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.

Experience

1. Global Lead Clinical Data Manager

   Sarepta Therapeutics

   Feb 2023 — Present

   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

  2017 — 2017

• University of Massachusetts Lowell

  Bachelor of Science, Chemistry

  2008 — 2011

• Boston College

  Clinical Research Certification

  2016 — 2016

Skills

• Teamwork
• Data Analysis
• Chemistry
• Powerpoint
• Microsoft Excel
• Microsoft Office
• Data Entry
• Editing
• • Basic Knowledge of Medical Terminology
• • Ability to Handle Change and Turn IT Into a Positive Opportunity
• Uv/Vis
• Pharmaceutical Industry
• Sop
• Gas Chromatography
• Databases
• • Energetic, Committed, Hard Worker
• • Proficiency in Microsoft Office Including Word, Powerpoint and Excel
• Research
• Time Management
• Titration
• Microsoft Word
• • Demonstrated Ability to Work Under Pressure
• Ftir
• • Strong Communication and Teamwork Skills