Skill required: Clinical Data Services - Clinical EDC Build
Designation: Clinical Data Svs Specialist
Qualifications:MSc
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 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.
Clinical Data Services involve the management and processing of data collected during clinical trials. This includes data collection, validation, storage, and analysis to ensure the data is accurate and reliable. The goal is to support clinical research by providing high-quality data that can be used to evaluate the safety and efficacy of medical treatments. These services are essential for regulatory compliance and successful trial outcomes. They often utilize specialized software and systems to manage the data efficiently.
Develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process.
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.
MSc