Suresh Bora Email & Phone Number

• Health care professional with 7+ years of Clinical research experience in Managing Phase I – III studies• Therapeutic areas: Oncology, Cardiovascular, Neurology and respiratory and Rare Disease• Well versed with Study Start-up, Conduct and Close-Out, Data Base Closure• Expertise in setting up the local Trial Master File (eTMF) Veeva Clinincal Vault, including tracking of documents. Maintain and close the local TMF ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.• Proficient in TMF Mapping and Remapping, TMF Reconciliation, and TMF Inspection readiness.• Experience working on Global Clinical Trials, Multiple Protocols, and Inspection readiness activities• Well-versed with Vendor Management and worked with multiple Vendors• Proficient in Study Planning activities, Developing Study Timelines, Study Summaries, Updating Investigational Brochures (IB), Planning and Conducting Investigator Meetings and ICF review• Assisted in Creating and Maintaining CRO correspondence, Informed consent forms, protocol and amendments, Financial aspects, IRB Submissions, IP accountability, and Drug supply Logistics• Assisted CRA in clinical monitoring visits (e.g. Remote monitoring, IMV, and close-out)• Experience in providing vendor management to site staff in RAVE, LabCorp, IVRS, IRT, ERT, LabLink