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.• Clarify, manage and successfully implement customer expectations, resolving conflicts whilst pursuing win-win scenarios.• Lead discussions of project requirements and planning.• Ensure project milestones are met as per agreed timelines and quality.• Coordinate and work closely with offshore Team Leads/Group leads.• Perform Operational QC as required.• Guide the creation of the data check specifications leveraging global standard validations and protocol specific edit checks.• Accountable for overall quality and integrity of study database for assigned studies and responding to post DB lock questions/queries. • Accountable for tracking the various data management activities using study reports/metrics.

• 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. • Create and maintain Data Management part of Study Master File.• Define integration specifications for external systems.• Declare data management systems ready for go-live by ensuring that all DM systems, documentation, validation checks, programming, access, availability and performance.• Analyze data from the Safety database and Project database.• Determine whether inconsistent data points exhibit and issue queries for data points that exhibit unacceptable discrepancies; document the status of events in a reconciliation spreadsheet.• Produce safety data listings for safety surveillance.• Ensure that all Safety Data Management activities are conducted in compliance with relevant regulatory requirements.• Execute Final database lock based on Study Deliver Team decision.• Design and deliver agreed status reports at a global level and study level. • Update study database based on Protocol Amendment/change in requirement.• Provide data to the Client internal review boards according to agreed timeframes and frequency.• Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.• Support Quality control steps for the trial.• Perform the Operational QC (sample QC) for the DM deliverables.

• 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. • Maintain Data Management related operational data flows.• Review reports and take actions as defined in the DMP or eCRF review manual.• Provide listings for review to study teams as defined in the DMP and process discrepancies appropriately. • Perform ongoing and final consistency checks, review protocol deviation and data listings as defined in the DMP and eCRF Review Manual.• Perform SAE Reconciliation between the Safety and Clinical study databases with supporting documentation and issue queries on discrepancies as appropriate. • Provide documents to be filed in the Study Master File. • Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements.• Participate in the Peer QC for the Junior staff who are in mentoring phase.

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

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

B.Sc, Zoology/Animal Biology