Vasanth Narayanamoorthy
Manager, CDM
Bengaluru,KA
Summary
CDM professional with 16+ years of experience in global clinical trials, specializing in line management, study oversight, resource planning, performance evaluation, and operational strategy. Proven ability to lead teams, optimize resources, and ensure compliance with SOPs and regulatory guidelines. Expertise in Medidata Rave, Inform, Oracle Clinical, OCRDC, Outcome, Merge, eCOS EDC, J-review, SAS Grid and other industry-standard tools. Strong track record of delivering projects on time, fostering collaborative environments, and achieving organizational goals.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Manager, CDM
Fortrea (Formerly Labcorp)
01.2021 - Current
- Responsible for the line-management of DM staff
- Manage direct reports to ensure proper training is assigned, completed and training records are up to date
- Manage direct reports to ensure utilization targets are met or exceeded, per job grade
- Supervise, mentor and evaluate performance of direct reports to ensure career development, interpersonal skills, and achievement of competency standards
- Be an active member of the DM Leadership team
- Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues
- Escalate any potential or actual issues to project team, upper management and/or sponsor company in the timely manner with suggested resolution and follow issues through completion
- Assist with the development and execution of training programs and ensure staff are trained and adhere to project-specific, global, standardized DM processes
- If applicable, responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.)
- Responsible for resource planning and management
- Maintain a comprehensive understanding of Covance DM SOPs, Work Instructions (WI) and guidance documents
- Possess knowledge of all company procedural documents that impact DM
- Assist with the generation and review of SOPs, Work Instructions etc., when applicable
- Participate in recruitment of new staff to DM
- Build and maintain good DM relationships across internal functional units and sponsors
- Demonstrate role specific Competencies and company values on consistent basis
- Financial authority as it relates to personnel and projects
- Any other duties as assigned by upper management
Project Data Manager
Labcorp (Formerly Covance)
07.2017 - 12.2020
- Responsible for the line-management of Data Management staff to ensure staff training records are up to date, utilization targets are met or exceeded, per job grade
- Supervise, mentor and evaluate performance of direct reports to ensure career development, interpersonal skills, and achievement of competency standards
- Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing
- Effectively plan and execute multiple Data Management projects simultaneously
- Assign tasks and responsibilities within Data Management to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business
- Ensure that assigned team executes Data Management functions in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs)
- Serve as Data Management Lead on selected projects
- Create study specific Data Management Plans (DMPs)
- Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification
- Oversee and contribute to creation of test data for entry screens and edit checks
- Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan
- Manage sponsor relationships and triage issues as appropriate
- Ensure that project team member performance supports project budget and delivery requirements
- Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
- Participate/attend Sponsor requested meetings as required
- Perform other duties as required by the Department
Senior Clinical Data Analyst
Labcorp (Formerly Chiltern)
05.2015 - 06.2017
- Work concurrently on multiple data management projects, and with little to no guidance from functional manager/PDM
- Provide input and assistance in the design of Case Report Forms (CRFs)
- Able to assist study specific edit check specifications
- Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager
- Perform necessary interpretations of compare output and provide feedback to DM Project Leader for resolution and database edits in DM
- Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes. Assist with provision of data management reports in support for project team, Clinical Research Associates (CRAs), investigative sites, sponsor as requested
- Demonstrate/describe data review processes to sponsors and auditors as and when needed
- Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in DM
- Work in a timely manner in accordance with all the activities specified in the agreed project budget, under the supervision and guidance of the Manager/Project Data Manager
- Provide guidance and training to Level 1 and 2 CDA colleagues as well as new hires
- Perform other duties as required by the Department
Clinical Data Coordinator
Quintiles Technologies Pvt. Ltd
04.2014 - 05.2015
- Serve as Data Operations Coordinator (DOC) for global studies with fewer operations staff or serve in a leadership role to a specific DM Task
- Perform comprehensive data management tasks including data review, writing and resolving data clarifications
- Perform database designer activities for technologies including develop and test databases and edit specifications not requiring extensive programming
- With guidance from DTL or Manager, manage project timelines and quality; determine resource needs; identify out-of-scope work
- Serve as back-up for Data Team Lead (with guidance)
- Perform comprehensive quality control procedures
- Solve issues through using the global issue escalation/communication plan
- Consult with Standards Group for process issues; communicate ideas for process improvement
- Understand and comply with core operating procedures and working instructions
- Meet objectives as assigned
- Develop and maintain good communications and working relationships with CDM team
- Interact with CDM team members to negotiate timelines and responsibilities
Data Management Analyst
Accenture Services Pvt. Ltd
08.2009 - 04.2014
- Ensure the Completeness and Validity of the clinical trial data that has gone through data entry
- Review and Resolve discrepancies identified by the system or through manual checks as per guidelines
- Issue Data Clarification Forms as and when required
- Track, review, update and close all DCF and FCF responses received
- Attend and participate in Client protocol meetings related data management activities
- Interact with the on-shore resources regarding data quality issues, study status, pending discrepancies and lock timelines during study calls
- Run JReview and eDM reports to clean clinical data
- Perform discrepancy management for SAE related discrepancies
- Perform Listing review, cleaning and consistency checks (as specified in DRP)
- Upon certification, train and mentor Data Managers
- Perform Data Management related Lock activities during lock timelines as priority
- Sending Discrepancy tracking reports and Page Approval/Re-approval reports to the CDQMs/STMs/CSs Site wise on a timely basis
- Escalating the issues and unresolved discrepancies to the concerned team
- Coordinating with team members in terms of reaching timelines for data base locks
- Perform IP Reconciliation, SAE Reconciliation on a timely basis and adhoc activities
- Perform peer reviews and providing technical assistance to the team members
Document Management Associate
Accenture Services Pvt. Ltd
- Process and Image documents related to Clinical Trials for Regulatory FDA Submission
- Indexing the documents to ESF Tool
- Archiving/Retrieving the documents from study start to study end
Education
M.Sc - Bio Medical Genetics
VIT University
Vellore, India01.2009
B.Sc - Bio Chemistry
Thiruvalluvar University
Vellore, India01.2007
Class XII - undefined
Hindu Higher Secondary School
Ambur, India01.2004
Class X - undefined
Hindu Higher Secondary School
Ambur, India01.2002
Skills
Team leadership
Certification
Have done Certificate Training Course in Clinical Data Management at Clinnovo Research Labs, April 2010.
Timeline
Manager, CDM
Fortrea (Formerly Labcorp)
01.2021 - Current
Project Data Manager
Labcorp (Formerly Covance)
07.2017 - 12.2020
Senior Clinical Data Analyst
Labcorp (Formerly Chiltern)
05.2015 - 06.2017
Clinical Data Coordinator
Quintiles Technologies Pvt. Ltd
04.2014 - 05.2015
Data Management Analyst
Accenture Services Pvt. Ltd
08.2009 - 04.2014
Document Management Associate
Accenture Services Pvt. Ltd
B.Sc - Bio Chemistry
Thiruvalluvar University
Class XII - undefined
Hindu Higher Secondary School
Class X - undefined
Hindu Higher Secondary School
M.Sc - Bio Medical Genetics
VIT University
Accomplishments
- Managed CDM team, achieved 100% utilization, and improved efficiency.
- Delivered complex studies on time and ensured regulatory compliance.
- Reduced cycle times and improved data quality through process enhancements.
- Mentored teams for career growth and supported succession planning.
- Maintained audit readiness and achieved successful inspection outcomes.
Additional Qualification
MS Office & HDCA (Honors Diploma in Computer Application).