Data Compliance Coordinator

Thermo Fisher Scientific; Berlin; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Data Compliance Coordinator, der die Qualität und Genauigkeit von Daten in klinischen Studien sicherstellt. In dieser Rolle koordinieren Sie Compliance-Aktivitäten und gewährleisten die Einhaltung von Vorschriften, um den Patienten im Mittelpunkt jeder Entscheidung zu halten. Sie arbeiten in einem dynamischen Umfeld, das sich der Verbesserung der Gesundheitsversorgung widmet und zahlreiche Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung bietet. Wenn Sie eine Leidenschaft für Daten und Qualität haben, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Erfahrung im Datenmanagement und der Qualitätskontrolle in klinischen Studien.
• Fließende Sprachkenntnisse in Deutsch und Englisch sind erforderlich.

Aufgaben

• Koordination der Compliance-Aktivitäten für klinische Studien.
• Überwachung der genauen und zeitgerechten Dateneingabe in das CRF.

Kenntnisse

Datenmanagement

Qualitätskontrolle

MS Office

Zeitmanagement

Multitasking

Fließend in Deutsch

Fließend in Englisch

Jobbeschreibung

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.

Alongside clinical research through our PPD clinical research 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 clinical 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.

Do you have a data entry / quality compliance background?

Interested in the dynamic clinical research industry?

We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Berlin, Germany.

This role will be responsible for oversight of data and quality control in the clinical trial process by ensuring all study documentation and source data are accurate and up to date.

Key responsibilities for a Data Compliance Coordinator are as follows:

1. Coordinate operational compliance activities on one or more studies to ensure successful delivery of the studies.
2. Ensure accurate and timely entry of all data in the CRF from source notes, track the flow of CRFs, queries, and patient recruitment statuses; report on the flow of data.
3. Maintain ISF and study trackers as delegated.
4. Follow the QC process and check that ICFs are correctly completed.
5. Ensure that protocol visit windows are scheduled according to protocol requirements and report deviations.
6. QC all supporting reports (laboratory reports / GP SDV / Consultant) to ensure review and sign-off by a physician within the appropriate timelines and flag any out-of-range values.
7. Assist with archiving procedures if required.
8. Assist monitors and sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
9. Identify quality issues (QI), report them, and apply CAPA reporting and root cause analyses.
10. Prepare and collate regulatory documents for submission.
11. Interpret and adhere to company SOP and COP, and assist with input during the review process.
12. Adhere to the rules and regulations of ICH, GCP, and other regulatory and ethical guidelines and data protection regulations.
13. Assist with drafting compliance reports.

Qualifications and skills required:

1. Fluent in German and English
2. Good time management and multitasking skills to coordinate several studies with multiple participants simultaneously
3. Proficiency in MS Office

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.