Dharmendra C.

About Dharmendra C.

Strategic Thinking. Operational Excellence. Relationship Building. Communication. Adaptability. The cumulative weight of my historical and ongoing involvement within the realm of clinical research is of paramount significance. Proficiencies in diverse competencies such as excellent communication skills, data analytics with tools such as advanced level excel, Power Business Intelligence, and Qlickview, building interpersonal positive relationship with team and partnered vendors, and proactive approach towards daily work which can be utilized for the potential project management for Biotechnology and Medical Devices companies. • Result-driven and meticulous clinical research professional with broad range of experience in planning, management, and execution of clinical trials. • Excellent understanding of ICH, FDA/EMA guidelines for clinical studies, including ICH E6 (GCP), Study Protocol requirements, Informed Consent requirements, IRB/IEC requirements, ADR/safety reporting requirements etc. • Knowledge of FDA regulations & requirements for Drug & Medical Device approval pathways like IND, NDA, BLA, IDE, 510k and PMA, including GMP and Quality System Regulations requirements.

Experience

1. Clinical Trial Associate

   Replimune

   Jun 2021 — Present · Boston, MA, US

   Prepare and draft Case Report Forms (CRFs), Study Reference Manuals, Pharmacy Manuals, Laboratory Manuals, Study Monitoring Plans, Safety Management Plans, Regulatory Management Plans and other scientific documents, which guide the execution of the study at each of Replimune’s numerous study sites Perform Regulatory Document review, including Investigator and Site-Staff CVs, medical licenses, financial disclosures, Form FDA 1572, IRB/IEC letters of approval, IRB/IEC approved documents (site-specific ICFs, Investigator’s Brochure, manuals, questionnaires, advertisement materials, etc.) Draft and document meeting highlights which cover subject areas including clinical operations, medical, regulatory, data management, safety, clinical drug supply and translational medicine Track document collection and review on a site-basis, entering study data into the Clinical Trial Management System through Veeva Vault CTMS To interpret data using Interactive Voice/Web Response System (IXRS) such as Suvoda IRT to register clinical trial site staff and track the amount of investigational supply shipped to and used by a clinical trial site pharmacy To provide insight in the development of SOPs and guidance documents which requires the understanding and application of regulatory requirements such as 21 CFR 312 and ICH E6 (R2). These are federal regulatory guidelines, which control Replimune clinical trials and FDA reporting requirements Create source data capture forms, subject screening and enrollment logs, subject informed consent logs, protocol deviation logs, and pharmacy accountability logs used during monitoring visits. Review, upload, classify and approve essential documents in the Veeva Vault electronic Trial Master File (eTMF), web-based, cloud application hosted by Veeva that enables real-time management and oversight of clinical trial documentation, allowing for the maintenance and management of the documentation, as detailed in GCP and other regulatory guidance/legislation

Education

• Northeastern University

  Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, 3.7

  2014 — 2016

• Ramanbhai Patel College of Pharmacy

  Bachelor's degree, Pharmacy, 3.0

  2008 — 2012