Mutharasi Arunachalam
Manager, Clinical data management (CCDM®)
Bangalore
Summary
Proactive and detail-oriented Clinical Data Management professional with over 16 years of experience in clinical data management. Skilled in leading and mentoring teams, streamlining workflows, and ensuring successful project execution with a strong focus on data accuracy and compliance. With more than 3 years of people management experience, adept at leading a high-performing team of approximately 20 members across varying experience levels, fostering talent development, and promoting a collaborative work environment to enhance efficiency and drive process improvements.
Overview
16
16
years of professional experience
2008
2008
years of post-secondary education
1
1
Certification
4
4
Languages
Work History
Manager, Data Management
Parexel
04.2023 - Current
- Oversee departmental activities including staff resourcing, assignments, quality control, and project deliverables
- Monitor performance metrics and drive initiatives requiring cross-functional collaborations
- Train, mentor, and allocate team members based on skill set and project needs
- Provide technical support and ensure compliance with SOPs and regulatory requirements
- Conduct performance reviews and foster a results-oriented work environment
Associate Manager, Data Management
Parexel
08.2021 - 03.2023
- Managed multiple studies, overseeing timelines, budgets, and compliance to quality standards
- Led teams in executing diverse data management tasks and ensured alignment with business requirements
- Developed risk management strategies and corrective actions for process improvements
- Collaborated with cross-functional teams including Clinical, Biostatistics, and Medical Writing
Data Management Lead
Parexel
09.2020 - 07.2021
- Led project-specific clinical data management deliverables, ensuring high quality and compliance
- Served as the single point of contact for clients regarding data management timelines and deliverables
- Analyzed study metrics to assess health and trends, identifying quality issues and corrective actions
- Coordinated project-level resourcing and functional staff allocation
- Conducted audits and regulatory inspections, implementing necessary corrective/preventive actions
Senior Clinical Data Analyst
Parexel
11.2019 - 08.2020
- Led data cleaning activities, protocol reviews, and quality control of clinical trial data
- Reviewed EDC screens, performed user acceptance testing, and executed functional QC activities
- Mentored junior analysts and provided technical guidance on data management processes
Lead Data Manager
ICON Plc
07.2017 - 10.2019
- Managed multiple projects from set up to closeout, involved in creating Data Management Plans, Data Review Plans, and other essential data management documents
- Involved in SAE reconciliation and third-party data reconciliation
- Ensured compliance with SOPs and regulatory guidelines while delivering high-quality datasets
- Involved in interim and final database lock activities, performing risk mitigation strategies
Clinical Data Coordinator
QuintilesIMS
07.2016 - 07.2017
- Managed data discrepancies, reconciliation, and compliance with clinical protocols
- Conducted vendor data reconciliation (PK, Biomarker, Central lab, and ECG)
- Performed quality control checks, site closure activities, and subject transfer management
Senior Clinical Data Manager
Accenture Services Pvt. Ltd.
09.2008 - 07.2016
- Conducted comprehensive data reviews for completeness, accuracy, and consistency
- Managed query resolution, discrepancy tracking, and SAE-related data reconciliations
- Coordinated with stakeholders to ensure timely database locks and study deliverables
- Developed risk mitigation plans and process optimization strategies for clinical data management
- Provided mentorship and training to junior staff, improving team efficiency and compliance
Education
B.Sc. - Biotechnology
Mumbai University
Skills
- Clinical Data Management (CDM)
- Team Leadership & Training
- Operations management & Strategic Planning
- People & Resource Management
- Data Integrity & Compliance
- Project & Risk Management
- Process Improvement & Optimization
- Audit & Regulatory Compliance
- Stakeholder & Client Coordination
Certification
Certified Clinical Data Manager (CCDM)
Disclaimer
I hereby declare that the details provided above are true to the best of my knowledge.
Awards Recognition
- Multiple Bravo Recognitions at Parexel
- Received JIRA Recognition from client for the final database lock
- PLATINUM Award, BPO Top Talent (2013-2014)
- Multiple Best Performer & Star of the Month Awards
- Client Appreciation Certificate for exceptional project execution
Timeline
Manager, Data Management
Parexel
04.2023 - Current
Associate Manager, Data Management
Parexel
08.2021 - 03.2023
Data Management Lead
Parexel
09.2020 - 07.2021
Senior Clinical Data Analyst
Parexel
11.2019 - 08.2020
Lead Data Manager
ICON Plc
07.2017 - 10.2019
Clinical Data Coordinator
QuintilesIMS
07.2016 - 07.2017
Senior Clinical Data Manager
Accenture Services Pvt. Ltd.
09.2008 - 07.2016
Certified Clinical Data Manager (CCDM)
B.Sc. - Biotechnology
Mumbai University
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