Data Manager II

About the role

The Data Manager II will coordinate and execute data management activities for clinical trials, ensuring that data is accurate, complete, and compliant with regulatory standards. This remote position supports the development and maintenance of data documentation while collaborating with internal teams and external clients.

Key responsibilities

• Independently manage data management tasks for assigned studies under general supervision.
• Develop, review, and maintain Data Transfer Specifications (DTS) for incoming and outgoing clinical data.
• Perform data extraction, transformation, cleansing, and formatting according to approved specifications.
• Design, execute, and document data validation and quality control checks.
• Test and verify data management deliverables, including execution of test scripts and validation of outputs before production release.
• Serve as the primary data management contact for routine study activities and communicate effectively with stakeholders.
• Collaborate across cross‑functional teams to resolve data issues and meet timelines.
• Adhere to GxP standards, SOPs, and applicable regulations such as FDA, GDPR, and 21 CFR Part 11.

Required profile

• Bachelor’s or Master’s degree in statistics, engineering, or a related field.
• Minimum 3 years of industry experience in data programming within a pharmaceutical or CRO environment.
• Familiarity with clinical trial research regulations and standards (GCP/ICH, CDISC/SDTM, GDPR, 21 CFR Part 11).
• Strong written and oral communication skills and high attention to detail.

Required skills

• Python
• SAS
• STATA
• R
• Microsoft Word
• Microsoft Excel