Trupti H Gaonkar

• Managing CDM RWS Team for Thane, Bangalore and Kochi locations (30 associates), Portfolio project oversee, Resourcing and Capacity management, departmental Strategies, onboarding and departmental training , initiatives for team and department, QC team, Metrics and dashboard
• Managing Partnership Clients for RWS studies
• Developing and implementation of the strategies and initiatives on Departmental level.
• Delivered business strategy and developed systems and procedures to improve operational quality and team efficiency
• POC for RFP/RFI for clients as representative of RWS CDM team
• Created/Formed of dedicated independent quality team for the Project, Metrics etc. Defined Quality Management Framework (eg: Quality control plan and Quality scorecard) to measure and provide assurance to client for defect free deliverable
• Creation/Review CDM specific SOPs and SWIs, Training material and assessments
• Working on the strategies planned for the development of the project and people.
• Created and implemented the Training Plan for the development of top performers associates within the team fo the career ladder
• Employed best practices and management controls to provide superior service to internal and external customers
• Maintaining qualified staff, communicated areas of accountability, and expected performance
• Optimized Resource management and Capacity planning
• Review performance results to target and take corrective measures with authorization and escalation
• Enact contingency plans, escalated and directed problems and issues, and participated in RCA CAPA to resolve them
• Interaction with Customers (internal and external) to build connections and nurture relationships
• Ensuring consistent standardized processes are implemented and department deliverables meet or exceed expected productivity , delivery, quality and financial targets; identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff

• Management of team (Thane, Bangalore), oversight of all the projects, resource management and capacity
• Manage trainings initiatives for complete RWS project as a Training manager
• Reviewed CDM specific SOPs and SWIs, Training material and assessments
• Delivered business strategy and developed systems and procedures to improve operational quality and team efficiency
• Employed best practices and management controls to provide superior service to internal and external customers
• Maintaining qualified staff, communicated areas of accountability, and expected performance
• Review performance results to target and take corrective measures with authorization and escalation
• Enact contingency plans, escalated and directed problems and issues, and participated in RCA CAPA to resolve them
• Interaction with Customers (internal and external) to build connections and nurture relationships
• Ensuring consistent standardized processes are implemented and department deliverables meet or exceed expected productivity , delivery, quality and financial targets; identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff

• IQVIA
• Manage staff (CML and CM)in accordance with organization policies and applicable regulations, including:
• Planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
• Work as a Project Oversight Manager who oversees the progress of the Project
• Managing escalations and attending the meeting for the progress of the Project
• Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process, Onboard, train, and mentor staff assigned to them
• Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review and mentored training experiences, as applicable
• Resource and Capacity management
• Deliverables meet or exceed expected productivity , delivery, quality and financial targets
• Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
• Lead and support continuous improvement initiatives

• Handling the supervisor role for the team as well as the hands-on on working on the Phase II and Phase II study for the RAVE and inform database
• Coordination of all the Data Management activities (end to end)
• Hands-on experience in RAVE database for Setup, Conduct (Query management) and Close out
• Activities of Studies
• Managed first RAVE study for client migrating from Inform for
• Coached team members in customer service techniques, providing feedback and encouragement toward reaching sales goals
• Involved in Complex Study Build and Change Management process in EDC (RAVE studies) for complex studies
• Involved in Impact assessment, risk analysis while working on Change management process
• As team leader handled more than 10-15 database locks for various Therapeutic areas specially Oncology and respiratory
• Coaching and mentoring of the team to achieve desirable quality output and to be complaint with SOPs/SWIs
• Provide input to Operations Manager on resources, scheduling and timelines as required.
• Provide guidance, coordinate and perform the assigned activities so as to yield timely and high quality output
• Involved in creation of Job descriptions for various jobs in Data management
• Responsible for creation of training plan and overall compliance for the same.
• Responsible for conducting workshops between various teams like Data Management and Study Set Up to ensure all team members working on client deliverables will be well versed with entire E2E process.

• Responsibilities as the Data Analyst and Junior Data Analyst were same however different with the experience in the working on the projects. working as primary DM for the studies.

• Supporting the Team leader for the set up, conduct and closeout activities for Rave database.

• Also handled the UAT for IVRS/IWRS and EPRO devices with executing test scripts and have done go-lives for various studies

• Responsible for delivery of Various Therapeutic area level training to operations team working on end to end data management

• Performed role of the validation lead for validation activities

• Mentoring the new joinees in the team wrt to the project deliverables and onboarding

• Perform Operational QC as required.

• Attending project meetings representing team.

• Gathering project information and planning for deliverables

• Suggesting and contributing for process improvements as appropriate

• Track metrics for the work done in coordination with the client.

• Provide input to Team leader on resources, scheduling and timelines as required.

• Provide guidance, coordinate and perform the assigned activities so as to yield timely and high

quality output

• Involved in creation of Job descriptions for various jobs in Data management

• Responsible for conducting workshops between various teams like Data Management and Study Set Up to ensure all team members working on client deliverables will be well versed with entire E2E process.

• Supporting the Team leader for the set up, conduct and closeout activities for Rave database.

Serving a pimary an secondary POC for studies

• Also handled the UAT for IVRS/IWRS and EPRO devices with executing test scripts and have done go-lives for various studies

• Responsible for delivery of various Therapeutic area level training to operations team working on end to end data management

• Performed role of the validation lead for validation activities

• Attending project meetings representing team.

• Gathering project information and planning for deliverables

• Suggesting and contributing for process improvements as appropriate

• Track metrics for the work done in coordination with the client.

• Checking and formatting the prepared clinical documents that are part of regulatory submission
• Protocol, Investigator’s brochure, Clinical Study Report, Clinical Trial Registry Summary, IND and NDA Annual Reports
• ECTD
• Quality check of the clinical documents for regulatory submission
• To work in coordination with all the members in the study team- internal and external for the development of clinical documents
• Project timelines amongst the study team for the development of document
• Format and check clinical documents according to the Standard Operating Procedures,
• Document Standards and Guidance document
• Review proper formatting of documents
• Ensure uniformity and consistency in the scientific content of the regulatory documents
• Work in co-ordination with team members
• Prepare the clinical documents with required quality standards within the target timelines
• Documents handling such as Protocols, Protocol amendments, Clinical Study reports , Clinical Pharmacology Study reports , CTD modules, IND as well as NDA reports and compilation of documents (dossiers)
• Then these documents are sent for publishing and then forwarded for the US FDA submission

• Developing and writing trial protocols (outlining the purpose and methodology of a trial);
• Presenting and preparing trial protocols to Ethics committee;
• Designing data collection forms, known as case record forms (CRFs);
• Monitoring the Study as per the SOP and SWI
• Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collecting completed CRFs
• Archiving study documentation and correspondence
• Preparing & documenting Final Reports (i.e
• Study Report, Protocol including Annexure)
• Performing Statistics, Graphs required in BA/BE studies i.e in Final Reports
• Obtained site approvals and gathered all documentation prior to beginning studies to meet rigorous standards
• Evaluated electronic data capturing systems for adherence to guidelines
• Coordinated with project lead for effective resolutions on study-related issues
• Monitored progress throughout duration of trial and documented activities for critical records
• Documented and reported clinical study progress and discussed potential opportunities and risks with respective project team members
• Oversaw investigational product accountability accuracy and investigational product inventory
• Assessed adherence to procedures, practices and all applicable regulatory requirements
• Personal Strength
• High personal integrity, and persuasive team-builder able to relate and create trust in all
• Highly articulate, confident, able to motivate and communicate to achieve exceptional business performance Dependable & reliable in supporting and enabling team effort to produce long-term sustainable development
• Persistent and flexible approach to mutually beneficial achievement of business plans and personal goals
• Adaptable to change within a demanding and pressurized business environment
• Achievements
• Single handedly managed complete thane team without manager intervention and also increased the team size - IQVIA
• Was selected by Vice president - IQVIA for RFP for interaction with Client for winning contract for new database
• IQVIA impact award- Operation excellence and