Vijayakumar Moses
Senior Manager, Clinical Data Management & Quality
Chennai,Tamil Nadu
Summary
Senior Manager CDM & QA with extensive experience in international clinical trials. Expertise in Clinical Data Management, project management, site management, strategic planning, and team leadership. Proven track record in ensuring data integrity, compliance, and timely delivery of results. Skilled in managing global stakeholders and vendors.
Overview
19
19
years of professional experience
3
3
years of post-secondary education
Work History
Senior Manager - Clinical Data Management & QA
KUR Research
Chennai, Tamilnadu
08.2024 - Current
- Directed CDM and QA teams to implement quality control procedures, ensuring compliance with FDA, GCP, and ICH standards while managing audits.
- Managed a diverse team of 15+ members, fostering a productive and engaged work environment through performance monitoring, mentorship, and career development guidance.
- Fostered strong collaborations with clients, stakeholders, and internal partners, including CFO, EVP, VP, Medical Directors and external vendors, to build lasting relationships and drive repeat business opportunities.
- Established operational standards (SOP and WI’s) to enhance efficiency, streamline processes, and ensure clinical trial data integrity, quality, and timeliness for exploratory or reporting purposes.
- Facilitated strategic meetings with leadership teams to drive organizational success and engaged with key stakeholders to provide strategic support and problem-solving.
Conducted several audits as a Head of Quality and handled CAPA as required. - Managed vendor relationships and contracts to ensure adherence to established agreements while addressing resource gaps and creating headcount requests with justifications.
- Delivered training on innovative quality improvement processes and established performance indicators to continuously improve CDM services.
- Enhanced customer satisfaction by resolving queries promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Served as a CDM expert, providing oversight on deliverables, compliance processes.
Sr. Manager - Clinical Data Management
Navitas Life Sciences
Chennai, Tamilnadu
04.2021 - 07.2024
- Led the implementation of CDM leadership strategies across Therapeutic Areas (TA) and processes, ensuring alignment with the vision and principles of partnering teams (Bio-metrics & Ops).
- Held full decision-making responsibility for all aspects of CDM execution (including within TA indications).
- Ensured optimal capacity management by allocating appropriate internal and external resources to meet the demands of the CDM function.
- Cultivated strong relationships with internal and external partners, including Medical Directors, Training and Risk Management, Quality Management, Statistics, Programming, Study Management Teams, and external vendors.
- Ensured clinical trial data met high integrity, quality, and timeliness standards for exploratory or reporting purposes, aligning with the needs of the Clinical organization.
- Served as a CDM expert, providing oversight and advice on DM deliverables and compliance processes.
- Managed vendor relationships and contracts to ensure delivery of clinical trial data adhered to established agreements.
- Established and monitored performance indicators to continuously improve CDM services, addressed resource gaps, and created headcount requests with justifications.
- Assessed quality gaps, submitted CAPAs, differentiated isolated events from systemic issues, and developed process improvement strategies and trainings.
- Partnered with Standards Group and Study Management colleagues to support data standards at portfolio and TA levels, balancing efficiency, flexibility, and value in data handling and usage.
- Directed and assigned work to CDM staff across multiple countries, serving as an escalation point for Data Managers leading studies within assigned TAs/indications.
- Attracted, developed, and retained top talent, provided situational mentoring, career development guidance, and promoted team building and a positive departmental culture.
Acted as designee of Director when appropriate.
Sr. Clinical Data Manager
Novartis Healthcare Pvt.Ltd
Hyderabad, Telangana
07.2012 - 04.2021
- Lead DM Study Start Up & Conduct activities (CRF Design/ Data Validation Specifications/ Query Handling/ Creating CRF Guidelines/UAT/Data Management Plan/Mock CRF's/ Data Transfer Specifications etc.)
- Managed multiple Data base lock activities in OC-RDC & RAVE platform as a TDM & DM support. (Oncology, Respiratory, Neurosciences).
- Responsible for projects in complex early phase clinical development programs .
- Excellent working knowledge of Clinical data management, CRF development Analysis, and general management.
- Provides review of Protocols for consistency checks.
- Well versed with Third party Data Reconciliations (LAB,QS,EG,IVRS,SAE, SPIRO,Local Labs etc.,).
- Support of the implementation of biomarker strategies for studies and projects and organization of the processes for pharmacokinetic data .
- Member of cross-functional teams, close co-operation with Statistics, Programming, DBP teams including the required project management and serve as key contact on topics related to clinical data management activities in the Core Study Team .
- Good command over communication & interpersonal skills.
- Extensive ability to troubleshoot and quality management skills. Team building skills.
- Provides feedback to peers in a constructive manner.
- Managed outsourced CRO studies with a 100% success rate.
- Mentoring and guiding Data Managers for the assigned trials & providing Metrics for the study status & periodic reports to the Global clinical team.
- Chairing global meetings daily to ensure and update study status from all stakeholders.
- Maintenance of global working practices and standards & adhering GCP guidelines.
- Ensuring Quality is not compromised at any point.
PCRF Designer II
Novartis Healthcare Pvt.Ltd.
Hyderabad, Telangana
10.2010 - 06.2012
- SME for Adobe Indesign, pCRF studies & Design office.
- Actively participates in CAPA (CRF and protocol alignment) and CRF review meetings to discuss CRFs for a clinical project and offer suggestions regarding CRF format and data collection requirements.
- Coordinate with data management and clinical team in designing therapeutic area pages and creating global standards templates.
- Hands-on experience with CRO & Service providing companies to get job done.
- Peer Reviewing and performing QA/QC for other trails.
- Make sure all questionnaires are designed adhering Global standard guidelines.
- Training and mentoring Junior CRF designers and anchoring pCRF workshops.
- As SME suggesting and innovating new designing methods for clear designs.
- Creating pCRF design for allocated studies and SME for standard page creation & approval. Designing & releasing News Letter for iDMA BO.
CRF Designer (Senior Associate)
Accenture Services
Chennai, Tamilnadu
02.2007 - 09.2010
- Analysis and CRF Design implementation.
- Trainer for Quark Xpress and Adobe packages& PRO's.
- Created e-CRF, PAPER CRF's & PRO.
- Senior designer for e-Newsletter Capsule.
- Generating automated e-CRF pages, peer Review and QC Checks.
- Part of Internal audit
- Created plans and communicated deadlines to ensure projects were completed on time.
- To analyses issues, assess options, and reach judgments, used critical thinking.
- Increased customer satisfaction by resolving CRF Design issues.
Web Designer & PHP Developer
Thendral.com
Chennai, Tamilnadu
11.2005 - 01.2007
- Created web applications using HTML, PHP & My SQL Photoshop.
- Provided optimal solutions, resolving technical and domain-related queries raised by clients.
- Implemented and Integrated various web page modules.
- Hosted web sites through FTP & Maintained client websites.
Education
Bachelor of Science - Computer Application
Madurai Kamaraj University
Madurai 06.2002 - 05.2005
Skills
Data Management
OCRDC, Medidata Rave, Medrio, DSG ecaselink, J-Review
Leadership & Team Management
Mentoring
Risk Management and Problem solving
Documentation
Communications
MS Office
Data oversight
Audit Ready and Compliance
Process Improvement
Study Setup, Conduct & Closure
Project Management - DM
Awards & Recognition
Novartis:
- Above & Beyond Gold award won twice for priority Study lock and for outstanding performance.
- Above & Beyond award for best performance & given training to the vendors in short period.
- Above & beyond & Star Impact Award for successful lock for high priority Asthma COPD trials.
- Best performer & Appreciation award for locking the complex trial with 100% quality.
- Appreciation award for locking retina & IHC studies.
- Appreciation award for SAS conference booklet design.
Accenture:
- Winner of Numero-Uno Award for best performance in the team at the year of 2007.
- Winner of Champions trophy Award for the best team in Pharma at the year of 2008.
- Quarterly Super Star award for best performance in the year of 2008.
Certification
NIDA Clinical Trial Network- GCP Certified
Lean Six Sigma Foundations - Linked-In & PMI certified
CSPO - Certified Scrum Product Owner
Language Proficiency
- English - Fluent in Speaking & Writing
- Tamil - Fluent in Speaking & Writing
- Telugu - Moderate Speaking
Hobbies
Reading Books (Historical Novels & Documentaries), Listening Music, Jogging & Singing.
Timeline
Senior Manager - Clinical Data Management & QA
KUR Research
08.2024 - Current
Sr. Manager - Clinical Data Management
Navitas Life Sciences
04.2021 - 07.2024
Sr. Clinical Data Manager
Novartis Healthcare Pvt.Ltd
07.2012 - 04.2021
PCRF Designer II
Novartis Healthcare Pvt.Ltd.
10.2010 - 06.2012
CRF Designer (Senior Associate)
Accenture Services
02.2007 - 09.2010
Web Designer & PHP Developer
Thendral.com
11.2005 - 01.2007
Bachelor of Science - Computer Application
Madurai Kamaraj University
06.2002 - 05.2005