Job
Description
Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert 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 world's 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.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.
