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Dynamic Senior Clinical Data Manager with extensive experience at top leading CROs, excelling in clinical data management execution and implementation. 20+ years in Clinical Data Management with over 7 years as Lead DM. Proven track record in developing comprehensive data management documentation and fostering excellent cross-functional team relationships through intentional communication. Highly skilled in Medidata Rave EDC with over 9 years of experience. Committed to ensuring timely, high-quality deliverables, audit readiness, and excellent internal and external client relationships. Emphasis on knowledge-sharing, ownership and accountability, and mentoring or junior associates.

Accomplished Clinical Data Management professional with over 5 years of progressive experience in clinical data review, data analytics, and quality oversight across diverse therapeutic areas. Expertise in ICH-GCP, FDA regulations, and client SOP compliance drives a proven track record of enhancing data accuracy, implementing process improvements, and conducting thorough scientific data reviews. A collaborative approach with Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS) ensures the integrity and readiness of high-quality data for regulatory submission. Recognized for strong leadership skills, meticulous attention to detail, and proactive communication within cross-functional teams.

Highly skilled and detail-oriented Registered Nurse/Clinical Data Manager,Reliable, well-organized, resourceful and diligent CDM leader offering 6+years of comprehensive experience in Phase I to Phase IV studies.
This comprises of 3 years in leadership roles at Clinical Research Organizations and Parent Pharmaceutical companies, gathering knowledge on Therapeutic areas such as Oncology, Endocrinology (Diabetes), Infections, Dermatology, and Respiratory. Gained experience of concurrently managing 25 data managers, 11 Phase III studies, 5 being oncology studies.
A leader Focused with an aim to adopt new tools and techniques that improve DM processes and boost inter-departmental collaboration.

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.


  Clinical Data Management professional with over 6 years of experience leading multiple studies through comprehensive planning and execution. Proven expertise in study start-up, conduct, and close-out activities, coupled with a strong capability in preparing e-Case Report Forms (eCRFs) and conducting User Acceptance Testing (UAT). Demonstrated success in data validation, query trend analysis, and maintaining Trial Master Files (TMF), with therapeutic knowledge spanning Cardiovascular disease, Respiratory disease, Oncology, Endocrinology, and Central Nervous System (CNS). Recognized for exceptional analytical skills and ability to foster collaboration across cross-functional teams while mentoring junior staff.


Bharathi Dharmaraj

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Senior Clinical Data Manager

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Senior Clinical Data Manager

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