Clinical Data Svs Specialist

About The Role
Skill required: Clinical Data Services - Clinical Database Programming
Designation: Clinical Data Svs Specialist
Qualifications:Bachelor of Pharmacy
Years of Experience:7 to 11 years
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.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?

Ability to establish strong client relationship

Ability to handle disputes

Ability to manage multiple stakeholders

Ability to meet deadlines

Ability to perform under pressure
Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred. o Extensive experience in database design, edit check programming, custom function programming and unit testing. o Experienced in various modules such as IVRS/RWS integration and Lab administration.

Medidata RAVE study builder certified preferred.
QualificationBachelor of Pharmacy