Anitha Bakthavatchalam
Bangalore
Summary
Clinical Data Management leader with extensive experience providing program-level oversight across multiple clinical studies. Recognized for owning data quality decisions, implementing Risk-Based Quality Management (RBQM) frameworks, and leading vendor governance and escalation activities. Accountable for data integrity, inspection readiness, and regulatory-facing audit support, with a proven ability to identify, mitigate, and document data risks rather than execute task-level activities. Strong cross-functional leader partnering with Biometrics, Statistics, Clinical Operations, and Project Management to deliver inspection-ready databases while mentoring data management teams to strengthen decision-making capability and compliance maturity.
Overview
13
13
years of professional experience
Work History
Senior Clinical Data Manager
AVANCE CLINICAL
06.2025 - Current
- Responsible for overseeing clinical trial data management activities in compliance with study protocols, ICH GCP guidelines, SOPs, and regulatory requirements. Accountable for data integrity and quality across all trial phases, while providing leadership, supervision, and mentorship to junior data management staff.
- Led the Clinical Data Management team, ensuring all activities were executed in strict compliance with study protocols, SOPs, ICH-GCP, CDISC standards, and sponsor requirements, consistently delivering high-quality, inspection-ready outcomes.
- Drove the development, implementation, and continuous improvement of globally harmonized Data Management SOPs, systems, process documentation, and working instructions in collaboration with cross-functional and quality stakeholders.
- Owned and maintained the global Data Management library, including CRF templates, edit checks, and eCRF completion guidelines, ensuring standardization, regulatory alignment, and scalability across studies.
- Provided program-level data management oversight across studies through protocol reviews, cross-project data reviews, and proactive identification and mitigation of data quality and compliance risks.
- Provided data management project leadership, chairing data-focused project meetings and coordinating deliverables with EDC Design, Statistical Programming, Statistics, PK, Project Management, and other Biometrics functions.
- Maintained oversight of broader Biometrics dependencies, consulting with functional leadership to anticipate risks, manage interdependencies, and support mitigation strategies.
- Oversaw medical coding activities, independent data quality reviews, and reconciliation of clinical databases with safety, laboratory, and third-party vendor data to support high-quality database locks.
- Partnered with Data Team Managers to investigate SOP deviations, CAPAs, and database unlocks, leading root cause analyses, lessons learned, preventive actions, and targeted training plans.
- Managed departmental performance, resource planning, and workforce strategy, including recruitment, hiring, onboarding, training, and performance management of Data Management staff.
- Allocated resources and responsibilities to optimize team capability, workload balance, delivery timelines, and budget expectations; actively monitored and escalated resourcing risks to senior leadership.
- Provided leadership, mentorship, coaching, and constructive feedback to Data Managers, Supervisors, and Managers, supporting career development, competency attainment, and performance improvement.
- Established Data Management competency frameworks and designed and delivered training programs to ensure staff achievement of role-based technical and leadership competencies.
- Represented Data Management in client and internal audits, leading issue triage, response development, and timely resolution of findings.
- Supported Business Development activities, including bid defences, proposal development, and data management input into budgets, resourcing models, and delivery strategies.
- Maintained awareness of emerging data management technologies and industry trends, contributing to process optimization and future-state planning.
- Performed additional leadership responsibilities aligned with organizational priorities and evolving business needs.
Associate Clinical Data Manager
FORTREA (Previously Labcorp)
08.2021 - 06.2025
- Led studies involving healthy volunteer and patient populations, multi-site, complex protocol designs, and strong client management, ensuring effective prioritization of workload and deliverables.
- Accountable for all DM deliverables as Study Manager, providing instructions to DM study teams and reviewing their output to ensure the highest quality, while adjusting resource allocations accordingly.
- Developed and maintained client relationships, implementing action plans from client satisfaction surveys, resulting in a 15% increase in Net Promoter scores (NPS).
- Collaborated with Project Managers to build timelines that meet contracted milestones, communicating with leads across disciplines and the full project team.
- Kept Project Managers and Biometrics management informed of pertinent project or sponsor-related information, including budget status, work scope changes, and timeline impacts.
- Coordinated receipt and inventory of all data-related information from clinical sites and vendors to meet deliverable timelines, ensuring appropriate documentation and procedures upon project completion.
- Tracked scope changes and worked with Project Managers to ensure Sponsor approval and processing of scope changes.
- Ensured service and quality met agreed-upon specifications per the DMP and scope of work.
- Contributed to writing, reviewing, and updating SOPs and associated documents as required.
- Represented DM and Biometrics in new business opportunities.
- Worked with the management team to develop and implement directional strategy, providing technical input and rolling out training/mentorship to DM staff.
Senior Clinical Data Coordinator (SLS)
ICON CRO
03.2017 - 07.2021
- Ensured strict adherence to protocols, SOPs, and GCP standards, ICH Guidelines, relevant laws and regulations.
- Developed eCRF, Data Validation Specifications, and Study-Specific Procedures coordinating with EDC Design, SAS Programming, Statistics, and PK leads.
- Data Management Local Lab Specific Procedures Creating LNR templates as per the Protocol/ e- CRF and study needs. Binder Checklist QC and conduct Monthly QC for the team.
- Reconciliation of data /Query Management /Perform quality check for the SAE tasks.
- Performed external data reconciliations, Queries, eCRF freezing and locking within EDC systems.
- Conducted UAT and collaborated with CDMS personnel to resolve issues.
- Responsible for resource allocation and providing feedback on resources.
- Identified potential risks and mitigations, communicated data-driven discussions to achieve database lock.
- Addressed issues of concern to the Project Manager as per Key Performance Indicators related to quality, productivity, performance, utilization, and staff wellbeing.
Dental Surgeon
Sailesh Dental Clinic
05.2014 - 02.2017
- Registered Dental Surgeon (Tamil Nadu Dental Council, Reg. No. 16852) with extensive experience in oral surgery (1300 extractions, 50 impactions), assisting 100+ ORIF cases, restorative dentistry (100+ cases), root canal treatments (50 cases), prosthodontics (dentures, jacket crowns), and orthodontics (fixed, removable). Organized annual free dental camps.
Tutor
Priyadarshini Dental College
08.2013 - 04.2014
- Worked as a college tutor, educating patients on oral health care. Conducted exams using IOPA, RVG, and OPG. Provided treatments including scaling, restorations, extractions, implants, impactions, root canals, orthodontics, and crowns/bridges. Maintained patient records, assessed budgets, and managed equipment stock.
Education
BDS - Bachelor of Dental Surgery
Tamil Nadu Govt Dental College and Hospital
12.2012
Skills
- People Management Skills
- Team Management
- Verbal Communication
- Written Communication
- Crucial Conversation
- Presentation Skills
- Decision Making
- Critical Thinking
- Problem-Solving
- Team Collaboration
- Customer Management
- Stakeholder Management
- Time Management
- Stress Management
- Managing Conflict
- Managing Confrontations
- Project Management Skills
- Protocol Interpretation
- CRF Completion Guidelines
- ECRF Specification
- Edit Check Specification
- User Acceptance Testing
- Review SAS
- Manual Edit Checks
- Listings
- Vendor Data Reconciliation
- Query Management
- SAE Reconciliation
- ETMF Filing
- Veeva Vault
- Quality Review
- Change Control
- Process Skills
- Understanding FTE Projections
- Work Allocation
- Reporting
- Dashboard
- Study Reports
- Master Patient Tracker
- PRM
- CPT
- Project Scope Planning
- Timeline Planning
- Identifying Risk
- Dealing with Risk
- Quality Management
- Project Budget
- Finance
- Audit Readiness
- Therapeutic Skills
- Oncology
- Hematology
- Metabolic
- Cardiovascular
- General Medicine
- Gastroenterology
- Neuroscience
- Infectious Disease
- Rare Disease
- Pulmonary
- Endocrine
- Dermatology
- Device
- Ophthalmology
- Respiratory
- Pediatrics
- Musculoskeletal
- Nephrology
- Immunology
- Tools
- Medidata Rave
- INFORM
- Medrio
- DATATRAK
- OC RDC
- OPTICON
- ORACAL Clinical DB
- Microsoft Tools
- Xcellerate
- PST
- SST
- QST
- DSM
- Review IBM Zelta
- I Review
- J Review
- Power BI
Coursework
Team Management, Verbal & Written Communication, Crucial Conversation, Presentation Skills, Decision making, Critical Thinking, Problem-Solving, Team Collaboration, Customer/Stakeholder Management, Time and Stress Management, Managing Conflict and Confrontations, Protocol Interpretation, CRF Completion guidelines, eCRF specification, Edit Check Specification, User Acceptance Testing, Review SAS/ Manual edit checks & listings, Vendor Data reconciliation, Query Management, SAE reconciliation, eTMF Filing / Veeva Vault, Quality review, Change Control, Understanding/ calculation of FTE projections & work allocation, Reporting and Dashboard (Study reports, Master patient tracker, PRM, CPT), Project scope and timeline planning, Identifying and dealing with Risk, Quality Management, Project Budget & Finance, Audit Readiness, Oncology, Hematology, Metabolic, Cardiovascular, General Medicine, Gastroenterology, Neuroscience, Infectious disease, Rare disease, Pulmonary, Endocrine, Dermatology, Device, Ophthalmology, Respiratory, Pediatrics, Musculoskeletal, Nephrology, Immunology, Medidata Rave, Veeva Vault, INFORM, Medrio, DATATRAK, OC RDC, OPTICON- ORACAL Clinical DB, Microsoft tools, Xcellerate (PST, SST, QST & DSM), Review IBM Zelta, I Review, J review, Power BI
Profile Summary
Clinical Data Management leader with extensive experience providing program-level oversight across multiple clinical studies. Recognized for owning data quality decisions, implementing Risk-Based Quality Management (RBQM) frameworks, and leading vendor governance and escalation activities. Accountable for data integrity, inspection readiness, and regulatory-facing audit support, with a proven ability to identify, mitigate, and document data risks rather than execute task-level activities. Strong cross-functional leader partnering with Biometrics, Statistics, Clinical Operations, and Project Management to deliver inspection-ready databases while mentoring data management teams to strengthen decision-making capability and compliance maturity., Enhanced operational efficiency by 55% through the implementation of Automated Local Lab Range Processing, reducing processing time from 28,000 hours to 2,800 hours., Optimized project timelines using DM Milestone Planner with Lead Indicators reducing Protocol to Go Live from 19 weeks to 13 weeks and shortening LSLV to DBL from 59 days to 47 days., Finalizing the Veeva Job Aids, Work instructions, Versions of SOPs-Author and Reviewer., SCDM Data Acquisition Workstream as SME providing high-level updates and strategic input on the scope and upcoming milestones. Speaker at SCDM 2025., Member at PHUSE working group on Risk Based Quality Management and Safety Analytics., Lead at ERG WEN Core Committee, collaborating with doctors for breast cancer awareness sessions., Veeva Enhancements- aiming to improve 100% efficiency and ease of use., Developed and finalized a QC process for SDV, DMR and Lab mass updates in Veeva., Implementation of a programmed comparison output to deliver top-quality results with integrity., Streamlined SAE reconciliation through automation, improving accuracy by 30% and reducing processing time by 40%.
Declaration Location
Bengaluru, Karnataka, India
Disclaimer
I hereby declare that all the above details are true and correct to the best of my knowledge and belief.
Timeline
Senior Clinical Data Manager
AVANCE CLINICAL
06.2025 - Current
Associate Clinical Data Manager
FORTREA (Previously Labcorp)
08.2021 - 06.2025
Senior Clinical Data Coordinator (SLS)
ICON CRO
03.2017 - 07.2021
Dental Surgeon
Sailesh Dental Clinic
05.2014 - 02.2017
Tutor
Priyadarshini Dental College
08.2013 - 04.2014
BDS - Bachelor of Dental Surgery
Tamil Nadu Govt Dental College and Hospital