Data Compliance Specialist

ThermoFisher Scientific; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

A global scientific company is seeking a candidate in Warsaw to manage site-level studies, ensuring data accuracy and regulatory compliance. Responsibilities include coordinating with monitors and assisting in compliance reporting. The ideal candidate will have strong attention to detail and knowledge of regulatory guidelines.

Qualifications

• Knowledge of ICH, GCP, and data protection regulations.
• Strong attention to detail for data entry and verification.
• Ability to assist with compliance reporting and archiving.

Responsibilities

• Manage studies at the site level.
• Ensure timely data entry in eCRF from source notes.
• Assist with query resolutions post-monitoring visits.

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job description:

• Study management at the site level
• Maintains ISF and study trackers as delegated and verifies that ICFs are correctly completed.
• Assists with data capturing activities on one or more studies across multiple sites and regions.
• Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.
• Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.
• Assists monitors and sponsor representatives with query resolutions after monitoring visits.
• Understands and adheres to company SOP and COP and assists with input during the review process.
• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
• Assists with drafting compliance reports.
• Assists in archiving procedures.
• Coordinates frequently with monitors and client representatives. Supports preparation of monitoring visit duties and clarifies any expectations relating to CRFs.
• Supports audit preparation and audit readiness.
• Identifies and escalates common data errors and trends and may assist with CAPA and problem‑solving methods.
• Cooperation with Vendors

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.