Sudeep Sahu

Experience

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  X

  Jan 2008 - May 2013

  Product Executive

    Preparation of New Visual-Aids Half-Yearly. Working with products related to Pain Management, Gastro-Intestinal range, Cough segment.  Correct errors in grammar, style, formatting, and syntax. Identify and fix flaws in logic and flow Follow style guides/templates provided by the team Review and format Word files to ensure as many compliance requirements are in the source file as possible Render the Word files into PDFs Maintain a strong customer focus Accountable for achieving timelines by managing activities efficiently and proactively; utilize ability to understand and apply team communication strategies to work products Coach new Product Executives or others requiring development in core areas Coordinate with vendors if any of the aforementioned activities are outsourced Understand key priorities and communication strategies across therapeutic areas and/or organizational units Maintain a working knowledge of product and disease state information Knowledge of medical terminology Show less

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  Omega Healthcare Management Services

  Jun 2014 - Sept 2015

  Medical Coder

   Undergone Class room training for one month and floor training for a week. Coding charts for US clients where both Facility & Physicians Procedures were involved.

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  IQVIA

  Oct 2015 - Dec 2018

  Clinical Analyst at IQVIA

   Conducted data review for inconsistent, illogical or inaccurate data. Knowledge of Electronic Data Capture (EDC, CTMS, IWRS) concepts and techniques and of clinical trial principles. Resolved queries of sites.  Performed listing reviews, AE reporting. Successfully trained Site Coordinators for proper understanding of DM concepts, mentored new team members, performed Peer Review. Evaluated and revised SOP's - Data Handling Conventions, Manual Review & Listing Review to reflect current discrepancy management practices, updated and authored CRF completion guidelines. Initiated Quality Reviews, identified all issues and proposed resolution.  Identified, gathered and supported the clinical activities for the Clinical Team on a day to day basis. Conducted workflow analysis of business processes and made recommendations based on findings. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information Setting quality standards and reviewing deliverables to the same for process tasks. Have successfully completed the Database Lock, working together with Clinical Data Management Team and Global Stakeholders. Has done both eTMF (Inventory & Comprehensive) review. Also have the experience of working on eTMF Health-check and Wingspan. Show less

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  IQVIA India

  Jan 2019 - Jul 2021

  Associate Centralized Monitoring lead

   Provide oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation Plan (COP) from Applications/ Analytics/ Therapeutics/ Quality Perform functional lead responsibilities for assigned project deliverables for specific customers or projects/specified. Independently manage assigned studies. Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. Also was associated with Site Activation whenever required for the studies. Maintained SRtE (Site Ready to Enroll) tracker. Acted as Study Start-Up Specialist Lead at project level; may directly interact with customers and sponsors as required. May serve as the main point of contact for all project-specific Study Start-Up Specialist activities. Coordinate with study teams, sponsors, clinical monitoring, clinical contracts, and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation, and site initiation. Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development, and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals. Oversee the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labeling, Import/export licenses, etc.). Support the Centralized Monitoring Advisor/Centralized Monitoring Manager in periodic review of Centralized monitoring training and/or identify the training needs of the team and provide inputs whenever required. Reviewing Monitoring Visit Reports. Conduct periodic reviews of site level KRIs and historic site performance according to Central Monitoring Plan Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit) Show less

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  Tata Consultancy Services

  Jul 2021 - Sept 2023

  Business Process Lead

  The TMF A is accountable for managing how well a study is progressing and driving Trial Master File (TMF) Completeness and Quality.Ensures the Clinical Trial Documentation is conducted in accordance with written standards, work instructions and ICH-GCP guidelines.Ensures that TMF is Inspection Ready and in alignment with the study agreed strategy and applicable milestones.Monitors and drives TMF Completeness and Quality for In-house and Outsourced studies.Serves as the TMF POC for any audits and inspections and assists with the development of corrective and preventative action plans in response to any findings.Liaises with Full-Service Outsourcing providers who are performing as part of the Cross functional team.Assists in the development and delivery of training materials and provides subject matter expertise.Provides expertise to global study team as needed to support study deliverable targets to agreed quality.Serves as the POC for the study team for TMF matters and liaises with TMF SMEs and process owners to aid in their understanding of requirements and associated solutions to ensure the TMF is Inspection Ready at all times.Addresses study team queries in a timely and efficient manner.Ensure all TCS and client trainings are completed in a timely manner. Show less

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  Teva Pharmaceuticals

  Sept 2023 - now

  Clinic Manager