EDC - Custom Function

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 and 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 utilise specialised 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.
Responsibilities:
Ability to establish strong client relationships.
Ability to handle disputes.
Ability to manage multiple stakeholders.
Ability to meet deadlines.
Ability to perform under pressure.
Requirements:
Overall experience of 4+ years with exposure to EDC platforms like Medidata.
Nice to have: RAVE EDC, Inform, Oracle Clinical, Veeva, etc. preferred.
Extensive experience in database design, edit check programming, custom function programming and unit testing.
Experienced in various modules such as IVRS/RWS integration and Lab administration.
Medidata RAVE study builder certified preferred.
Good to have: MSc.

Experience
7-11 yrs