 Clinical Affairs Data Coordinator
Location: Clydebank, Scotland
Salary: Competitive Our client is looking for an experienced candidate to provide support their many Clinical Study teams undergoing innovative research.
This role will report into the Biostatistician and will form part of the new team of data management within the organisation.
Responsibilities
- Participate in the review of Clinical Protocols, Case Report Forms, Reports and Statistical Analysis Plans
- Develop and maintain Data Management Plan(s)
- Develop Case Report Form(s)
- Lead the process of determining EDC database specification
- Develop Data Transfer Agreement(s)
- Develop test scripts for User Acceptance Testing
- Maintenance/tracking of EDC user management
- Perform close-out audit, as specified, for closing of study trial in EDC
Qualifications
- A Bachelor’s degree in a science or mathematical related field
- Previous data management experience in a related industry/company.
- Working knowledge of GCP and GMP
- Knowledge of GCP, GMP, Clinical Trial processes and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.
Experience of AE Coding would be desirable but not essential.
The Company
The company has experienced an unprecedented level of growth and investment in the recent years and as such, is looking to expand their team specialising in medical device research and manufacture. Our client prides themselves on their positive culture and support of career progression.
The salary on offer is highly competitive and our client offers a generous benefits package and company performance bonus.
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