Rohit Jain

Experience

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  Flamingo Pharmaceuticals Ltd

  Aug 2009 - Mar 2010

  IPQA officer

  • Providing Line Start up clearance.• In process checks and online review of documents and logbooks• Monitoring and maintaining of GMP on shop floor• Checking of logbooks on shop floor• Calibration of IPQA instruments• Sampling at various stages of Manufacturing and Packing• Cleaning validation, Hold time study,• Stability Sampling and charging• Dispensing raw materials• Validations• Finished goods checking.• BMR, BPR issuance and their review• Preparation of BMR, BPR• Issuance and retrieval of monthly formats• Preparation of SOP and their formats• Compilation of documents• APQR preparation and trends• Issuance of Change controls, Deviations and CAPA and maintaining their logs and reviewing them. Show less

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  M.J. Biopharm Private Limited

  Mar 2010 - Mar 2011

  QA officer

  • Providing Line Start up clearance.• In process checks and online review of documents and logbooks• Monitoring and maintaining of GMP on shop floor• Checking of logbooks on shop floor• Calibration of IPQA instruments• Sampling at various stages of Manufacturing and Packing• Cleaning validation, Hold time study,• Stability Sampling and charging• Dispensing raw materials• Validations• Finished goods checking.• BMR, BPR issuance and their review• Preparation of BMR, BPR• Issuance and retrieval of monthly formats• Preparation of SOP and their formats• Compilation of documents• APQR preparation and trends• Issuance of Change controls, Deviations and CAPA and maintaining their logs and reviewing them. Show less

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  Sitec Labs Pvt Ltd

  Mar 2011 - Dec 2013

  Clinical QA

  • Quality review of all study level documents.• Online monitoring of BA/BE studies and blood donation and screening of volunteers• Reviewing of Pathological Reports• Performing internal audits and vendor audits.• Issuance of Change controls, Deviations and CAPA and maintaining their logs and reviewing them.• Dispensing of Investigational products• Validations and calibration records review.• Quality review of clinical study report prepared for regulatory submissions.• Archival of documents (external and internal Archival)• Preparation of Training plan and providing training to new recruits• Preparation of Trends analysis• Preparation of SOP’s, manuals, and other documents. Show less

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  Watson Pharma Pvt Ltd

  Dec 2013 - Sept 2015

  QA Auditor

  • Quality review of all study level documents.• Online monitoring of BA/BE studies and blood donation and screening of volunteers• Reviewing of Pathological Reports• Performing internal audits and vendor audits.• Issuance of Change controls, Deviations and CAPA and maintaining their logs and reviewing them.• Dispensing of Investigational products• Validations and calibration records review.• Quality review of clinical study report prepared for regulatory submissions.• Archival of documents (external and internal Archival)• Preparation of Training plan and providing training to new recruits• Preparation of Trends analysis• Preparation of SOP’s, manuals, and other documents. Show less

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  IQVIA

  Aug 2015 - Sept 2018

  Centralized Monitoring lead

  • Review of subject level data, identifying trends, protocol deviations, non-compliances & site performances and thus suggesting necessary CAPA or providing insights to avoid them.• Knowledge of data analytics implied in clinical trials for smooth functioning of project.• Handling KPIs and setup of KPIs and Risk management including analysis and mitigation.• eTMF set up and review at different levels and follow up with sites or monitors for timely inspection readiness of eTMF.• Handling Investigator payments process to sites from central location.• Assisting Project team in Project activities and meeting project deadlines.• Preparation of study documents e.g., Manuals, Project instructions etc.• Centralized Monitoring activities forming a part of site management.• Leading team of personnel in a project and guiding them on project aspects for meeting project deliverables.• Reviewing site visit reports authored by monitor and maintaining issue log and escalating issues to Project Manager.• Access management for various systems.• SME at department level played a key role in set up of department and part of many departmental and process improvement initiatives.• Training provided to new recruits; refresher trainings conducted on floor along with the assessments.• Set up of training evaluation questionnaires.• Preparation of SOPs, training documents, process maps and guidance documents• Leading calls with different internal and external stakeholders for planning and overcoming issues at project level.• Follow up with sites and study team to meet study deliverables. Show less

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  Tata Consultancy Services

  Sept 2018 - Feb 2022

  Clinical Support Specialist

  Clinical role• Assisted sponsor to set up study by supporting study start up activities such as to set up initial TMF, IP release checklist review, follow up & review of essential documents for study start up.• Approval, Activation of site in sponsor database for IP shipment to trigger IP shipment during study start up, maintenance and De-activation of site in database during study closure and early termination of study to ensure drug shipment compliance for the study.• Review of essential clinical trial documents for correctness & completeness during study start up, conduct, and closure phase.• Update & Maintenance of sponsor systems such as CTMS & electronic archival of study documents• Assisting sponsor in creating supporting documents for clinical study reports as per client’s SOP’s.• Assisting Project team in Project activities & meeting project deadlines.• Review of financial disclosures & SPOOS processing i.e., investigator financial interests• Access management for various systems.• Follow up with sites and study team to meet study milestones.• Managing and supporting clinical activities for Japan regional studies and interacting with the client stakeholdersTMF Analyst role• Ensure Clinical trial documentation is conducted in accordance with the client’s written.standards, work instruction and ICH/GCP guidelines• Ensure the TMF is inspection ready and is in alignment with the study agreed strategy and milestones.• Monitor and drive the TMF completeness & quality for inhouse & outsourced studies.• Served as TMF point of contact to study team & assisted project team with the development of CAPAs to address TMF related audit/inspection observations.• Provides project management expertise to global study team as needed to support study deliverable targets to agreed quality standards.• Address study team & stakeholder’s requests in timely & effective manner• Liaise with service partners to ensure eTMF completeness. Show less

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  Saama

  Feb 2022 - Jun 2023

  Product Owner

  • Gathering technical and functional client requirements to build tailor-made solution/ product/visualization platforms for risk identification and tackle unmet business need.• Creations of documents such as User Requirement specification, Data transfer agreements, Client Specification documents etc.• Creating mapping specifications for Developers.• Managing Product for different clinical research organizations /Sponsors• Communication with cross functional teams on Upcoming updates.• Helping with Data consolidation and management of clinical trial data to fit the analytical needs of the research organization.• Data review and data profiling and functional testing of the product release for client.• Manage product deliverables and timelines by coordinating with Senior Management and other Business partners.• Work with internal business partners in ensuring communication is sent out through the right channels regarding the latest product enhancements, fixes and versions.• Schedule Demonstration of the product enhancements features with the customers.• Data analysis and review of client source database to formulate actionable Key performance indicators (KPI) Design, Development, quality analysis and UAT of the developed products for Life science and healthcare organization.• Creating data quality (DQ) rules and Source to target mapping (STTM) documents.• Data validation of the different data layers for data integrity, proper data exporting, transfer and loading of data.• Experience of working on Clinical Trial data reporting and visualization platform.• Playing active role in developing unique product for Pharmaceutical Supply Chain analysis and management.• Acting as SME for life science and clinical research domain providing training to the IT developers.• Providing training to newly recruited team members.• Managing team of 5 direct reportees. Show less

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  IQVIA

  Jul 2023 - now

  Associate Product Owner

  • Participating and coordinating in product workshops.• Gathering technical and functional requirements from internal and external stakeholder’s.• Writing user stories for product feature/APIs development and enhancement.• Creating documentations such as Release scope, Release notes, User Requirement specification, Data transfer agreements, Client Specification documents etc.• Providing demos to internal and external stakeholders on newly developed features and enhancements.• Communication with cross functional teams on Upcoming updates.• Manage product deliverables and timelines by coordinating with Senior Management and other Business partners.• Work with internal business partners in ensuring communication is sent out through the right channels regarding the latest product enhancements, fixes and versions.• Implementing scrum principles and conducting different sprint meetings for product development.• Working closely with scrum teams for creating product iterations.• Prioritizing product backlog, product debt and tech debt etc.• Analyzing support tickets to identify trends which can be turned into feature or enhancement. Show less