17 Aug
|
Randstad
|
Hyderabad
17 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