Data Compliance Coordinator

vor 2 Wochen

Frankfurt am Main, Deutschland PPD Vollzeit

PPD, now Thermo Fischer'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 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.

We are currently looking to attract a **Data Compliance Coordinator in our Synexus Research site in Frankfurt**.

The Data Compliance Coordinator provides quality control support to the clinical trial process by ensuring all study documentation and source data is accurately captured in CRF and up to date. You will be responsible for maintaining the Investigator Site Files (ISF) as well as performing quality checks and answering any CRF queries in a timely manner.

**Key roles and responsibilities of the Data Compliance Coordinator are**:

- Coordinates operational compliance activities on one or more studies to ensure successful delivery of the studies
- Ensures accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data
- Maintains ISF and study trackers as delegated
- Follows the QC process and checks that ICF’s are correctly completed
- Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations
- QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
- Assist with archiving procedures if required
- Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits
- Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses
- Prepares and collates regulatory documents for submission
- Interprets 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 need the following skills and experience**:

- Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
- Good working knowledge of Business English
- Appropriate MS Office Skills
- Basic medical terminology knowledge
- Good attention to detail

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement**

**#LI-TK2

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