Data Compliance Coordinator - Frankfurt am Main, Deutschland - Thermo Fisher Scientific
Beschreibung
PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
**At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health**
Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.
Do you have a data entry/quality compliance background? Are you interested in the dynamic clinical research industry?
We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Frankfurt, Germany.
Key responsibilities for a Data Compliance Coordinator are as follows:
- Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed.
- Assists with data capturing activities on one or more studies. May provide support across multiple sites and/or regions.
- Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.
- Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations.
- May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed.
- Learns 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
To be considered for this exciting opportunity you will require the following skills and experience:
- Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
- Proficiency in German both written and verbal
- Good English working knowledge, comparable to minimum B2 level
- Appropriate MS Office Skills
- Good attention to detail
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
LI-TK2 #AES
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