Nadjia Edwards
Clinical Trial Manager, Clinical Operations
- Role
- Clinical Trial Manager at Alnylam Pharmaceuticals
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Nadjia Edwards
Associate Manager in Clinical Operations and Development with experience in study…
Experience
Clinical Trial Manager
Feb 2025 — Present · Cambridge, MA, US
Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. • Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies • Provide leadership and input into global subject/patient recruitment plans. • Effectively communicate and interact with Key Opinion Leaders. • Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor. • Manage strategic study operations including: study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc. • Participate in Case Report Form design, user acceptance testing in partnership with data management • Generate country specific Informed Consent Form(s). • Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies. • Provide support to clinical trial managers within and/or across programs. • Budgets, timelines, and forecasts preparation for clinical studies. • Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs; which may include lading sub-teams and/or acting as a liaison between groups. • Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.
Education
Worcester Polytechnic Institute
Bachelor's degree, Biomedical Engineering
2012 — 2016
UMass Boston
Master of Arts - MA, Critical & Creative Thinking - Science in a Changing World
2017 — 2020
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