Clinical Data Manager, crawley, west sussex
Client:
Northreach
Location:
crawley, west sussex, United Kingdom
Job Category:
Other
-
EU work permit required:
Yes
Job Views:
3
Posted:
22.08.2025
Expiry Date:
06.10.2025
Job Description:
Overview
We are seeking an experienced Clinical Data Manager to join our Clinical Operations team. In this pivotal role, you will oversee and manage fully outsourced data management activities to ensure high-quality, timely, and compliant clinical data to support regulatory submissions and clinical development goals. This is a new role where you will take ownership of data oversight across all clinical studies. You will collaborate closely with CROs, vendors, internal cross-functional teams, and external stakeholders to ensure data integrity and operational excellence.
Key Responsibilities
* Serve as the primary data management contact for assigned clinical studies.
* Oversee CROs and vendors to ensure timely, high-quality delivery of all data management activities in compliance with GCP, ICH, and regulatory requirements.
* Review and approve essential data management documentation, including Data Management Plans (DMPs) and validation specifications.
* Ensure efficient execution of database go-live, interim reviews, and database lock processes.
* Monitor data quality and resolve issues proactively to maintain data integrity.
* Support regulatory submissions by ensuring availability of clean, compliant datasets.
* Stay current with industry standards and regulatory trends to drive continuous improvement in data management practices.
Must Haves
* Significant clinical data management experience, preferably in a biotech or pharmaceutical environment.
* Experience overseeing fully outsourced data management with CRO oversight.
* Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical data.
* Proficiency in EDC systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform) and data review tools.
Why Join Us?
* Make a significant impact in an innovative and growing biotech company.
* Collaborative and innovative work environment.
* Competitive salary and benefits package.
* Remote working with regular team meetings.
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Created on 22/08/2025 by JR United Kingdom
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