Clinical Data Manager (12 Month FTC) - Edinburgh Hybrid
Lorien's long-standing, successful and very impressive client, with a great global-reaching product line and offices very commutable from Central Edinburgh, Fife, West Lothian and the surrounding, is looking to recruit a Clinical Data Manager on a 12-month fixed term contract basis who can bring a proven track record in the domain and skills across the following to the table.
The Clinical Data Manager position is an integral part of the Clinical team, responsible for providing comprehensive data management support to ongoing studies and projects. As the Clinical Data Manager, you will be tasked with ensuring the accuracy, integrity, and timely delivery of clinical data throughout the study lifecycle.
Your key responsibilities will include:
Overseeing, alongside the Director of this area, all related documentation including developing and maintaining robust Data Management Plans and Data Handling Manuals and setting up and maintaining the Trial Master File
Coordinating study and project status updates for relevant meetings
Coordinating the development/review of clinical research documents, such as protocols and CRFs
Oversee EDC database specification and UAT processes, including test script drafting, eCRF design, edit checks, and validation rules/documentation
Performing data quality assessments/reconciliation, query management, and data locking activities
Assisting with the preparation of data for statistical analysis and regulatory submissionsWhat they're looking for:
Degree in a scientific discipline, as well as a demonstrable track record of clinical data management within a Pharmaceutical/MedTech/similar regulated setting
Proficiency in clinical database applications (e.g. EDC/CTMS)
Ideally but not necessarily - Programming skills with the likes of SQL and/or Python
Strong understanding of GCP and GMP, as well as relevant regulatory requirements and jargon and research/trial processes
In addition to these technical skills, you'll demonstrate excellent analytical and problem-solving abilities, strong interpersonal skills with the ability to work with people at any level, and comfort working collaboratively in a global, virtual team environment.This company is known for its commitment to innovation, quality, and customer-centricity. As the Clinical Data Manager, you will have the opportunity to contribute to the development of cutting-edge medical technologies that have a direct impact on peoples' lives the world over.
If you are excited about the prospect of being part of a great and evolving organization, we encourage you to apply for this Clinical Data Manager FTC today with your latest CV for immediate consideration.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy