Clinical Trial Project Management of Phase II and III Global Clinical Trials (GCTs) in India using Veeva Clinical Vault (VCV), Veeva Quality Vault (VQV) and Enterprise Regulatory Vault (ERV).Therapeutic Areas:1. Cardiovascular 2. Respiratory 3. Renal4. Metabolism 5. Rare Diseases

• Negotiating the site budgets with the principal investigators (PIs) and executing the clinical trial agreements (CTAs) for Phase III, IV, and IIS studies in India for new chemical entity (NCE - Emrok), biosimilars (Wosulin, Glaritus & Wepox), regenerative stem cell therapy (Healrex: Autologous Growth Factor Concentrate - AGFC) and branded generics (Spasmoproxyvon Plus, Glimaday and Hapid). • Assigning and managing the project team as per the study requirement. • Development and revision of departmental SOPs. • Reviewing CRA's site visit documents (visit reports and follow up letters). • Reviewing and approving the travel plan and budgets of CRAs. • Updating internal stakeholders about the progress of the study and liaising with them for any requirement. • As per SOW, negotiating with vendors (Insurance, Medical writing, Biostatistics, data management, clinical supply, central labs and translation agencies), finalising the vendor and ensuring that activities are completed within timelines, budget and with optimal quality. • Conducting external audits for vendors and CROs. • Preparing monitoring plan, project management plan (PMP), risk management plan (RMP) as per the study specifications and protocol and training the CRA on the same. • Training the team on study related documents. • Perform co-monitoring visits to ensure quality of data generated. • If required, accompanying the CRAs in site qualification visits (SQVs), site initiation visits (SIVs) and site monitoring visits (SMVs). • Organize and present at investigator meetings (IMs) and internal meetings. • Supporting in preparation and submission of EC dossiers, CTRI registration and presentation for SEC meetings. • Reviewing power point presentations (ppts) prepared by CRA for investigator meetings (IMs) and site initiation visits (SIVs). • Tracking budgets of ongoing studies, forecasting of budget and tracking utilization of resources.

1. Managed Abbott's global medical affairs (GMA) non-interventional studies (NIS):- ₹60 crores multi-country post-marketing observational registry study (in Russia, China and Turkey)- RWE and investigator initiated studies (in US, Europe, APAC and AfME).2. Managed GMA NIS budget on a monthly, quarterly and yearly basis.3. Managed CROs for fully outsourced GMA NIS from contract signature to contract closure.

For P&G Health:Procter & Gamble Health Limited (company's website) - https://www.pghealthindia.com/• Managed Phase II/III Global Clinical Trials (GCTs), local Phase IV trials, Non-interventional Observational studies (NIS), retrospective and prospective real world evidence (RWE) studies and Investigator Sponsored Trials (ISTs) which includes:1. Vendor Management - Vendor identification, review of proposal, vendor qualification, vendor selection, drafting of contract, finalizing the scope of work, budget finalization, contract signing and execution.2. Financial Management - Vendor creation, preparation of purchase order, payment forecasting, review of invoices, tracking payments and closure of contracts.3. Vendor Oversight - Drafting of milestones, essential documents creation, drafting of project management and other study related plans, ensuring that the CRO's personnel follow ICH GCP and company's SOPs.4. Study and Site Management - Communicating with the PIs and the CRO's personnel to ensure that the start-up (feasibility, site selection and site initiation), conduct (recruitment, treatment and follow-up) and close-out (database lock, end of study report and publication) phases are completed as per the project's milestones. Conducting risk management, budget monitoring and control.5. Stakeholder Management - Communicating successfully with external (Health Authorities, Ethics Committees and Medical Writers) and internal (R&D, Medical Affairs, Biostatisticians, Regulatory, Drug Safety, Marketing, Finance, Legal, Quality Assurance, Product Research, Supply Chain and Procurement teams) to ensure timely delivery of projects.

Line management of 11 direct reportees including CRAs and Sr. CRAs which included:1. Recruitment and Selection2. Performance Management3. Performance Appraisal4. Conflict Management5. Audit and Inspection Support6. Project Management Support

Consultant for Pfizer:• Handled Medical Quality Oversight (MQO) activities for Africa and Middle East (AfME) which included countries like Algeria, Morocco, Nigeria, Tunisia, West Africa and Regional Medical Teams having Regional Medical Directors based in London, Paris and Dubai.• Supported the 5 Audit Coordinators from the above AfME countries during the Medical Quality Assurance (MQA) group’s 3 Pfizer country office internal process audits. Interviewed by internal MQA auditors. • Conducted Root Cause Analysis (RCA) using 5 Whys, 6Ms and Fishbone techniques; drafted and followed up for the completion of Corrective and Preventive Actions (CAPAs) post the MQA audit report and collected, reviewed and archived the evidence for the completion of CAPAs on the local SharePoint site and internal audit quality management system (QMS - Trackwise).• Ensured that the CVs, Job Descriptions (JDs) and Organization Charts are updated as per the Quality Management System’s (QMS) SOP for all new medical colleagues. • Conducted monthly Quality Reviews (QRs) as per the Country Quality Plan (CQP) for various Medical, Regulatory, Safety and Commercial activities and ensured that there are no unreported AEs/SAEs.• Resolved Regulatory team’s Artwork issue and Safety team’s PSUR issue in a timely manner.

• Ensured accurate and timely trip report completion and trip report review and the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate.• Followed project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues and assured the implementation of project plans as assigned.• Ensured site monitoring responsibilities for clinical studies are conducted according to Covance Standard Operating Procedures, ICH Guidelines and GCP by CRAs in the APAC region.• Ensured follow up on action items and protocol deviations and liaised between CRA, CTL and PM for timely resolution of issues.• Responsible for the timely and appropriate communication to the clinical operations team.• Liaised with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.• Assisted with training, mentoring, and development of new employees especially CRAs in APAC region.• Reviewed progress of project and initiated appropriate actions to achieve target objectives. • Contributed to improvements to enhance the efficiency and quality of work on assigned projects.• Responsible for the report review and project management of the sites from United States of America, Canada, Thailand, Philippines, South Korea, Malaysia, Taiwan and China.

For Pfizer:• Development, implementation and maintenance of the local quality management system• Quality Performance Analytics• Conducting Medical Compliance related trainings and audits• Promoting quality with internal and external customers through various training programs• Coordinating with Information Technology (IT) department to implement new IT solutions in the Medical Research Division.• Subject matter expert on Promotional Materials and Customer Engagement Programs1. Delivered a 3 hour lecture on Audits with special emphasis on site audits to MSc in Clinical Research students of Tata Memorial Hospital, Parel on 04-Apr-2015.2. Delivered a 5 hour lecture on CRA Role and Responsibilities to PGDCR course students of Dr. D. Y. Patil Hospital, Navi Mumbai on 15-Nov-2014.

For BMS:Assisted the clinical project/ study manager in strategic planning and development of project management tools, resource allocation for outsourced studies, risk management for complex protocols, managing investigator performance and improving outcomes and identifying strategies for patient recruitment and retention.• Actively involved in contract and budget negotiation with the KOL sites during the study startup process.• Provided support and timely follow-up for all audit and quality assurance activities.

For Pfizer:• Implemented and monitored clinical trials to ensure sponsor objectives and investigator obligations are met and studies are compliant with protocol and regulatory requirements.• Performed site pre-study evaluation, site initiation, interim monitoring, and site close-out visits to ensure investigator and staff comprehend and are in compliance with protocol, FDA regulations, ICH GCP guidelines, Indian GCP, ICMR Guidelines and Schedule Y.• Proactively functioned as a part of the clinical study staff to help execute all study related procedures, which included but were not limited to: the collection, review and tracking of regulatory documents, the approval of Informed Consent Forms, development, collection, and tracking of Confidentiality Agreements and Site Contracts, the preparation and distribution of study start-up documents.• Performed source data verification, retrieved Case Report Forms (CRFs) and tracked query resolution for EDC as well as paper CRFs. • Continuously tracked the day-to-day progress of clinical site activities. Updated the clinical study subject status at regular intervals. Identified problems/issues and reported findings to Clinical Trial Manager.• Performed investigative site file reconciliation; collected and reviewed for content, consistency, new or updated site-related essential and non-essential documents for study.• Executed the timely reporting of Serious Adverse Events to members of the Drug Safety Team and served as the lead CRA on the final reconciliation of SAE’s reported to federal regulations (FDA), those recorded at participating sites, and the Clinical Data Management System.