Clinical Data Svs Associate

Skill required: Clinical Data Services - Clinical Data Management

Designation: Clinical Data Svs Associate

Qualifications:Bachelor of Pharmacy

Years of Experience:1 to 3 years
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What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH).

What are we looking for Ability to establish strong client relationship
Roles and Responsibilities: Update BOT query sheet as and when requested by the TDM.Ensure completeness and validity of clinical as well as external data.Generate missing page report and track missing pages, as required.Track discrepancy and query status of assigned studies/Investigative sites as applicable.Review data from first data received to last data received and for selected tasks supporting the interim analysis/final database lock by operating in a continuous cleaning process.Perform DD pass activities as needed.Perform review for SDTM Data sets (SITS), P21 and other applicable reports.Share the weekly study metrics with TDM.Act as back up for TDM and lead study related meetings/document MOM and perform task allocation applicable for Data Manager, as needed.Upload standard reports/manual listings (DQPM listings) to central client location as guided by Lead Data Manager or client counterparts.Maintain an issue log to track and resolve discrepancies. Ensure issue clarification/follow-up until closure per the Issue Escalation Process/guidelines, as applicable.Interact with the TDM/Lead regarding data quality issues and assist them in tracking, monitoring the progress of data review activities.Accountable for high quality and on time delivery for assigned deliverables.Achieve the applicable SLA/KPI metrics.
Qualification
Bachelor of Pharmacy