Nilesh Damle

Program Management & Strategic Leadership:

• Oversaw and managed a portfolio of complex clinical data management projects, ensuring the Data Management Team delivers against project milestones, timelines, and quality goals in line with corporate objectives.
• Developed and implemented data management strategies for clinical trials, data collection, and management processes align with requirements.
• Led cross-functional collaborations, fostering productive relationships with stakeholders, including study teams, vendors, sponsors, and cross departments, to ensure the seamless execution of clinical trials and data management activities.
• Directed the planning and execution of clinical data management programs, guiding the use of data management technologies and methodologies to optimize trial processes and enhance data accuracy, security, and accessibility.
• Provided oversight of clinical data workflows, ensuring all data-related deliverables were completed within established timelines, budget, and scope.
• Managed scope, budget, and resources for Clinical projects within the broader program, ensuring that project resources were effectively allocated and utilized, and any scope changes were appropriately handled.
• Ensured inspection-readiness, maintaining comprehensive documentation and ensuring the Trial Master File (TMF) was consistently up to date and audit-ready.

Vendor & FSP Oversight:

• Led FSP (Functional Service Provider) relationships, overseeing external vendor deliverables, and ensuring that data management tasks were executed in accordance with Service Level Agreements (SLAs).
• Monitored vendor performance and led initiatives to optimize data management processes across the clinical trial lifecycle, ensuring compliance with contractual terms and driving continuous improvement in service delivery. (e.g., Streamlining Rave Amendment strategy and efforts, as a member of PCOE, supported the Sponsor for inputs/UAT during the development stage for various Next Gen Tools: Dolphin Metrics, Smart Query Tool, Rule E implementation, Single Query DCH template, Edison & Ocean Migration, Entimice related, and Veeva Vault.). These Initiatives aimed to generate Client Value addition and cost saving (approx 5 to 8 FTE savings, approx. $32,000 to $40,000 savings per month.
• Supported change management initiatives that improved overall data management functionality, implementing process improvements and system enhancements for more efficient and secure data collection and storage.
• Provided oversight for the end-to-end lifecycle of data management activities, ensuring the timely delivery of study data, resolving escalated issues, and leading Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) for data-related concerns.

Project Management and Leadership:

• Led multiple global projects ranging in size and complexity, ensuring effective project planning, execution, and resource management, and aligning the clinical data management deliverables with broader program objectives.
• Ensured high-quality delivery through proactive oversight of project timelines, budget management, and team performance, consistently meeting or exceeding Key Performance Indicators (KPIs).
• Directed a team of Clinical Data Managers, overseeing performance reviews, professional development, and mentoring for senior and junior team members.
• Collaborated with senior leadership to forecast future resource needs, identify potential project risks, and develop solutions to ensure the smooth execution of clinical data management strategies.
• Led internal and external audits and inspections, providing insights into best practices for data management and ensuring that the organization maintained its reputation for compliance and operational excellence.
• Process Improvement and Cross-Functional Leadership
• Acted as the point of contact for all clinical data management issues, resolving escalated problems, and identifying innovative solutions for complex challenges within clinical IT systems and data management processes.
• Represented Data Management and Clinical Programs on cross-functional project teams, contributing to key decision-making processes, and driving alignment between clinical data management activities and broader clinical program objectives.
• Led and participated in continuous improvement initiatives, including the development of new Standard Operating Procedures (SOPs) and Work Instructions (WPs) for data management activities, enhancing overall project delivery efficiency.
• Coached and mentored teams, identifying opportunities for skill development and ensuring the continuous growth of the next generation of leaders within the clinical data management team.

• Handled techniques like- Preservative efficacy test for cosmetics, Neutralizer validity test, Kill efficacy test, Claim support studies, Test method validation, Antimicrobial studies, Preparation and maintaining of microbiological stock cultures, Upstream related Microbial activities · Monitored validations for- Autoclave, Laminar Air flow, Fermenter

•Ensure that all project-related data management tasks are completed in accordance with Syneos Health Clinical standard practices from commencement to closure of a project.

• Identify and quantify resource requirements for ongoing and future projects.
• Manage billable and non-billable time for the assigned group.
• Line Management and performing Performance Management of reportees.
• Actively involved in departmental Level Lean Six Sigma Projects and Process improvement
• Providing oversight support to clinical studies, client stakeholder management, and project management-related resourcing and forecasting activities.
• Supervise, Coach and Mentor Staff.
• Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, create development Plans, Mentoring and Coaching related plans.
• Providing Management level Monthly Dashboard Metrics. Interview, hire, onboard and train new staff as appropriate.
• Identify data management project issues and alert Senior Department Management with a view to remedial action.
• Interact with other departments to ensure a high level of client satisfaction through successful execution of projects.
• Managing Clinical Studies as Study Oversight Manager and Single point of contact for Client and Lead.

• Lead DM projects: Conduct and set up studies.
• Oversee and perform UAT activities and other conduct related activities
• Lead Oncology project and GI Therapeutic Program. Well versed with therapeutic areas (Oncology, GI, and Respiratory).
• Involved in preparing the SOP’s and Work instructions for UAT, Query Management Process and QC process.
• Involved in performing the QC and provide QC oversight for the Project.
• Involved in QC Metrics, Efficiency Dashboard reporting
• Coordinate with clients and manage the UAT activities.
• Lead discussions of project requirements and planning and resourcing.
• Onboarding of new joinees and involved in imparting training for new team members
• Updates/reviews and approves all required data management documentation.
• Monitor the progress of all data management activities for the project to ensure that project timelines are met. Directs activities associated with data integration.
• Maintain Monthly Efficiency Report and Monthly quality report.
• Monitors the data management process for the project to ensure that work is proceeding in an efficient manner.
• Serves as Data Management contact with sponsor managing their expectations, noting and responding to out-of-scope work.
• Has participated in the development of Standard Operating Procedures (SOPs) and guidelines and process improvement initiatives.
• Conducting training for the Data Managers on RAVE UAT, other UAT tasks, Query Management and overall process training. Ensure that they scale up and get cross functional training.
• CRF designing using Adobe Frame maker, Handling Query Management tasks for studies.
• Drive the Process optimization and Process improvement initiatives

• Past Work Experience with Cognizant Technologies Solutions Ltd from Aug2008 till Oct 2011 in various Job roles summarized as below:
• Lead Data Manager (Worked at client Pharma location in Osaka Japan, From Nov2009 to Apr2011).
• Worked in Cognizant ltd, India from Apr2011 as Offshore Lead Data Manager and Team Leader. and Data Analyst (Cognizant ltd, Mumbai, India: from Aug 2008 to Nov 2009).
• Presented RAVE Study set up essentials during the Investigator and Site monitor training in Hong Kong on 23-27 Feb2011 attended by the key stake holders Responsibilities handled: · Lead discussions of project requirements and planning · Single point of contact for the client, for all data management deliverables during study setup. •Coordinate with the Client and vendors for setting up the Clinical database, IVRS/IWRS set up, ePRO, Central Labs and Local Labs set up and associated activities. •Ensure adherence to company and client SOPs. •Review resource estimates for data management activity for allocated studies.
• Study Project planning •Oversee and guide creation of all study documents relevant to clinical data management activities • Responsible for database integrity, review and testing •Ensure study setup milestones are met according to agreed timelines, with high quality • Participate in defining strategies for new processes and technologies at regional or global level •Manage and implement customer expectations successfully •Manage Horizontal Data Management teams across geographies.
• Mentor data management center staff, Provide technical oversight, guidance and supervision to data management center staff •Participate in study kick-off meetings and other meetings during study setup phase
• Provide inputs to costing algorithms
• Monitor quality, efficiency and timeliness across functions, note trends, identify improvement Opportunities, and ensure sharing of lessons learnt, across geographies
• Leading all clinical data management activities for studies in conduct phase and being primary point of contact for client through database lock and close-out activities

• Review and understand the study protocol and the timelines.
• Conduct sponsor User Acceptance Testing (UAT) of EDC systems to assure screen design matches protocol and edits are programmed and operating as intended and escalate the errors identified to the Sponsor CDM study manager.
• To maintain and update the entire study files as per the requirement of the protocol.
• To be aware and updated of the Sponsor quality standards and undertake any relevant training for the same if required
• Escalate any discrepancy in the clinical data to the Sponsor CDM study manager as appropriate. •Provide data listings in the required format as documented
• Perform external checks to handle manual discrepancies and action the same.
• Review the resolved discrepancies and close where appropriate.
• Coordinate with the Sponsor CDM study manager with respect to any unresolved queries and close the same
• Attend relevant Client study teleconference.
• Understand and review dataset specifications, Understanding of Subject Visit Walk Through. Awareness of external vendor data requirements.
• Ensure reconciliation of all the study data as per the study manger’s request.
• Processing of all external data, performing data loads/deliveries via external alliance portal (EAP), external data utility (EDU), SPECTRE (Phase2 - 4) Execution of SAS checks
• Completion of Final Third Party Vendor data reconciliation i.e., PGx, LABs.Freeze case books instream & Final Freezing of the database.

• · Worked on Fermentation Process Development and handling Upstream Related Activities · Handled techniques like- Preservative efficacy test for cosmetics, Neutralizer validity test, Kill efficacy test, Claim support studies, Test method validation, Antimicrobial studies, Preparation and maintaining of microbiological stock cultures, Upstream related Microbial activities · Monitored validations for- Autoclave, Laminar Air flow, Fermenter