Data Compliance Coordinator

TN Germany; Berlin; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A leading company in clinical research is seeking a Data Compliance Coordinator in Berlin. This role focuses on overseeing data and quality control in clinical trials, ensuring accuracy in documentation and compliance with regulations. Ideal candidates will be fluent in German and English, possess strong time management skills, and be proficient in MS Office. Join a mission-driven team dedicated to improving health outcomes globally.

Qualifikationen

• Proficiency in managing multiple studies and participants.
• Experience in data compliance and quality control.

Aufgaben

• Coordinate operational compliance activities across studies.
• Ensure accurate and timely data entry in the CRF.
• Follow ICH, GCP, and other regulatory guidelines.

Kenntnisse

Fluent in German

Fluent in English

Time Management

Multitasking

Tools

MS Office

Jobbeschreibung

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About Thermo Fisher Scientific

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Our Work in Clinical Research

Alongside clinical research through our PPD portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

Position: Data Compliance Coordinator

We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Berlin, Germany. This role will oversee data and quality control in the clinical trial process, ensuring all study documentation and source data are accurate and up to date.

Key Responsibilities

1. Coordinate operational compliance activities across studies to ensure successful delivery.
2. Ensure accurate and timely data entry in the CRF from source notes, track CRF flow, queries, and patient recruitment statuses; report data flow.
3. Maintain ISF and study trackers as delegated.
4. Follow QC processes and verify correct completion of ICFs.
5. Schedule protocol visits according to requirements and report deviations.
6. QC supporting reports to ensure review and sign-off by physicians within timelines, flag out-of-range values.
7. Assist with archiving procedures if needed.
8. Support monitors and sponsor representatives during visits and query resolutions.
9. Identify and report quality issues, apply CAPA and root cause analysis.
10. Prepare and collate regulatory documents for submission.
11. Interpret and adhere to SOPs, COPs, and assist with review input.
12. Follow ICH, GCP, and other regulatory and ethical guidelines, including data protection regulations.
13. Assist with drafting compliance reports.

Requirements

• Fluent in German and English
• Good time management and multitasking skills for managing multiple studies and participants
• Proficiency in MS Office

Our Mission and Values

Our mission is to enable our customers to make the world healthier, cleaner, and safer. We are a team of over 100,000 colleagues sharing values of Integrity, Intensity, Innovation, and Involvement—working together to accelerate research, solve complex scientific challenges, drive innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

Equal Opportunity Employer

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