16 Aug
|
Randstad
|
Hyderabad
16 Aug
Randstad
Hyderabad
Role & responsibilities
- The Specialist, External Data Acquisition and Delivery (EDAD) is responsible for end-to-end management of non-CRF (Case Report Form) data.
- Responsible for the development of recent or amended low to medium complexity Data Transfer Specifications (DTS) with minimal supervision for assigned studies or Clinical Development Unit (CDU).
- Perform external data reconciliations between EDC and vendor data systems to ensure data integrity, completeness, and consistency across all data sources.
- This role ensures the external vendor data is accurately transferred, reconciled against clinical database, and cleaned in accordance with the study protocol and Data Management Plan (DMP).
- Act as the primary technical point of contact between clinical data management and vendors.
- Works collaboratively within Clinical Data Management functions, other external stakeholders and External Data Vendors to ensure the delivery of appropriately structured external data as per Regeneron SOPs and best practices.
- Provides mentoring for less experienced associates. Ensures that all External Data Services activities are performed according to quality standards and regulatory requirements.
- Partners with External Data Vendors, CRO partners, Clinical Data Management, and cross-functional stakeholders to guide cross-functional teams and ensure compliance with Regeneron SOPs, regulatory requirements, and industry best practices.
📌 Specialist, External Data (Hyderabad)
🏢 Randstad
📍 Hyderabad