Senior Specialist, External Data Acquisition and Delivery (EDAD)

Randstad; Hyderabad; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Regeneron is seeking a data management professional to develop DTS templates in line with CDISC standards. You will author DTS with stakeholder input, ensure data formatting and structure meet regulatory requirements, and monitor DTS progress across study programs.

You will respond to external data provider queries, resolve data issues, and collaborate across functions to create new test codes while maintaining adherence to Regeneron standards and timelines.

Qualifications

• Experience managing multiple clinical data types and formats (biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data).
• Knowledge of database structures and protocol review related to clinical data management.
• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Understanding of Data Management and External Data processes and industry best practices.
• Proficiency with extracting data into SAS, CSV, and XML formats.
• Familiarity with EDC platforms (Medidata Rave, Veeva, Oracle Inform).

Responsibilities

• Develop new DTS templates aligned with CDISC requirements.
• Author DTS with stakeholders ensuring compliance and consistency.
• Respond to data provider queries to ensure complete, correctly formatted data.
• Track DTS status across data types and programs to meet study timelines.
• Ensure external data structure is compliant with DTS templates.
• Support data structure issue resolution for assigned studies.
• Liaise cross-functionally to create new test codes.
• Process change requests to update DTS for studies.

Skills

CDISC standards

Data management

Regulatory compliance

SAS/CSV/XML data formats

EDC platforms knowledge

Education

Bachelor's degree in Life Sciences or Computer Science or related field

Tools

SAS

CSV

XML

Medidata Rave

Veeva

Oracle Inform

Job description

Role & responsibilities

• Responsible for the development of new DTS templates in alignment with CDISC requirements. This includes:
• Authoring the DTS in collaboration with stakeholders, ensuring consistency and compliance with the applicable standard Data Transfer Specification templates and processes.
• Responding to external data providers and internal stakeholder queries to ensure data will be delivered are complete, in the correct format and structure.
• Tracking DTS status across different data types and programs. Ensure DTS development dates are met as per study timelines.
• Ensuring external data structure is consistent and compliant with appropriate standard Data Transfer Specification Templates.
• Supporting data structure issue resolution for assigned studies.
• Liaising cross functionally to facilitate the creation of new test codes.
• Processing change requests to update existing DTS for assigned studies.
• Support locking and archival of external data.
• Provide review of protocol requirements, vendor specifications, and operational data flows with minimal supervision.
• Maintenance of all Data Transfer Specification (DTS) documents, ensuring consistency and compliance with Regeneron standards, processes, templates, and timelines.
• Provide guidance on External Data Services to CROs, internal stakeholders, and external vendors across assigned data types.
• Monitor data trends to identify potential risks to data integrity or protocol deviations early in the study life cycle.
• Perform external data reconciliation activities between EDC and vendor data systems across all studies.

Preferred candidate profile

• Experience in managing multiple clinical data types and formats, e.g., biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data is required.
• Basic knowledge of database structures and protocol review as relevant to clinical data management is preferred.
• Demonstrates knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
• Demonstrates basic knowledge of Data Management, External Data processes, and industry best practices.
• Proficiency and experience with extracting data into SAS, CSV, and XML formats is required.
• Knowledge of EDC platforms (e.g., Medidata Rave, Veeva, Oracle Inform, etc) and experience with external data reconciliation and query processes between EDC and vendor data systems.