Shruti Goel

About Shruti Goel

Currently working as a Medical Scientist at Syneos Health. Over the past 5 years I have gained experience in clinical development, medical data review, study related documents/plans development, clinical data review and risk-based monitoring. I have worked on multiple indications and delivered high quality result using various tools while maintaining integrity, scientific value and quality of Medical Data from clinical trials. Skilled in Microsoft Excel, Word, Power Point, RAVE and Veeva Vault.

Experience

1. Medical Scientist

   Syneos Health

   Apr 2024 — Present · Gurugram, IN

   Develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan) in collaboration with Medical Director and sponsor-Performs regular medical review of data listings and data visualization; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews-Authors medical data queries and reviews query responses, approves query closure inassociation with Medical Director-May assist Medical Director in patient profiles review, scientific review of other study level data,protocol deviation review, creation of Medical Review Summary report as needed. Partners with Medical Directors for medical data review meetings and safety review meetingsincluding slide preparation as needed-Manages project scope of work, objectives, and quality of deliverables to ensure the projectspecific milestones and timelines are met. Serves as primary interface between internal team,customers, and vendors in the areas of medical data review and eligibility review-Collaborates with study team members including Clinical Operations, Data Management, DrugSafety and Pharmacovigilance, and Project Management (set-up and/or lead meetings asappropriate) to identify risks related to data integrity and subject safety. Escalates ongoing andnewly developed study concerns such as at-risk project deliverables and out of-scope tasks tothe project leads in a timely manner-Acquires basic understanding and knowledge of ongoing protocol designs and disease relatedterminology and pathology-Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), andGood Clinical Practices (GCPs), all enterprise policies, standard operating procedures, workinstructions, and project plans. Adheres to customer policies and standard operating procedures,as required in project plans.

Education

• Clini india, Pune

  Advanced Post Graduate Program In Clinical Research And Management, Clinical research

• Panjab University, Chandigarh

  Masters in sciences, Biotechnology

  2016 — 2018

• Goswami Ganesh Dutta SD College, Chandigarh

  Bachelor of Science - BS, Biotechnology (hons.)

  2013 — 2016