Saravanakumar Chinnaraj Email & Phone Number

Chennai, TN, IN

Chennai, Tamil Nadu, India

Act as Clinical Data Management SME & Project Manager and serve as main POC for customers to deliver solutions.Work closely with Clinical trial sponsors, CROs at the executive and study team level to bring solutions.Drive customer implementations to successful launch by providing data management inputs.

• Provide guidance and supervision to the direct reports for assigned project work; review in detail all work done by them before it is reviewed by global teams.
• Review and provide input to Project Data Management Plan as and when required.
• Support Quality control steps for the trial. Coordinate QA/QC for the study at milestones.
• Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.
• Responsible for overall quality of deliverables from the Data management team.
• Ensure compliance and Audit readiness among the team members.

• Coordination of all the Data Management activities.
• Review and provide input to Project Data Management Plan.
• Validate patient diary questionnaires for a project/study.
• Review CSP and provide updates for inclusion in CSP amendment/s.
• Based on review of CSP, identify need for new standards.
• As applicable, create, review Mock CRF Design, Annotated CRF and expanded CRF.

• Review and action queries on an ongoing basis and update database appropriately.
• Develop eCRF Review Manual and eCRF Instructions (for EDC studies).
• Review EDC Core Configuration against study requirements and assess need for any amendments.
• Develop mock CRF, Unique CRF casebook and annotated CRF.
• Create and maintain CRF data standard document.
• Perform UAT according to Validation Plan for applicable Data Management systems.

Master'S Degree, Clinical Laboratory Science/Medical Technology/Technologist

M.Sc, Clinical Laboratory Science/Medical Technology/Technologist

B.Sc, Zoology/Animal Biology