External Data Services Manager

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee daily clinical data science operations and assist the team in achieving quality results.

• Spearhead the creation of Data Transfer Specifications (DTS) documents for external data suppliers and research collaborators.

• Draft DTS documents and address inquiries from external providers and internal stakeholders.

• Monitor the status of DTS across various data types and programs, ensuring that completion dates align with study schedules and deliverables.

• Guarantee that data structures are uniform and adhere to the relevant data templates.

• Assist with data reconciliation and address inquiries regarding data structures.

• Collaborate across departments to facilitate the development of new test codes.

• Act as an extended member of the Clinical Study Team.

• Supervise and educate users on DTS and related documents.

• Contribute to the enhancement of external data processes.

• Ensure that study teams comply with CDISC standards for external data.

• Adhere to regulatory requirements associated with clinical protocols, biomarkers, imaging, eCOA, blinding, and analysis expectations.

• Process change requests to amend existing DTS.

• Enhance DTS templates to facilitate data harmonization and downstream analytics.

• Provide oversight for external data management to vendors, encompassing functional discussions, partnership processes and standards, portfolio status, communication, and escalation.

• Review and contribute to eCRF and EDC builds in relation to external data requirements.

⛳️ Requirements

• A minimum of 8+ years of experience in external data services.

• Preferred expertise in biomarker data types and/or imaging data for both oncology and non-oncology studies.

• Experience with various data types/formats.

• Proven experience in managing clinical, biomarker data, eCOA, and imaging data.

• Demonstrates comprehensive knowledge of all relevant regulations, including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.

• Exhibits advanced knowledge of Data Management processes and industry best practices.

• Required advanced knowledge and experience in extracting data into SAS, CSV, and XML formats.

• Must have the legal right to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.