Clinical Trial Management System Specialist
1 month ago
Emply Denmark is a pivotal part of the Sanos Group, consisting of around 200 employees. We are the world-leading Contract Research Organization (CRO) specialized in osteoarthritis and other musculoskeletal diseases.
We provide top-tier scientific and clinical trial services to the biotech and pharmaceutical industries.
Innovative Solutions for Rapid ResultsWe believe in innovation. Pioneering study designs and flawless execution are essential for developing life-changing medication quickly, intelligently, and efficiently.
We leverage our deep-rooted research in connective tissue diseases like osteoarthritis and rheumatoid arthritis where we deliver unparalleled value.
Focused Expertise for Maximum ImpactRather than spreading ourselves too thin, we concentrate our efforts on a few therapeutic areas and let the science drive our business, not the business drive the science.
Comprehensive Support Every Step of the WayFrom crafting study designs and writing protocols to managing trials and navigating regulatory affairs, Emply Denmark covers it all under one roof.
Our comprehensive approach ensures that every aspect of your clinical trial receives careful attention and expert handling.
Renowned Worldwide for ExcellenceOperating at the forefront of international medication development, Emply Denmark is renowned worldwide for our scientific prowess and operational excellence.
About the RoleWe are looking for a Clinical Trial Management System Specialist to join our team within Operational Excellence.
This key role plays a crucial part in ensuring that we use our CTMS to its full potential, enabling us to maintain oversight of our studies.
You will be working closely with our Documents System Manager, who shares similar responsibilities for our eTMF.
- Ensure proper implementation, configuration, setup, access management, and maintenance of the CTMS to enable good study oversight.
- Establish work instructions and best practices for CTMS use and maintenance.
- Train and support current and future end-users in the use of the CTMS.
- Participate in system upgrades including validation documentation.
- Ensure data loads into CTMS from relevant systems.
- Establish reports and dashboards for reporting progress of clinical trials – ultimately reporting these to Senior Management and Board of Directors.
The salary for this role is estimated to be between €80,000 - €110,000 per annum, depending on experience and qualifications.
RequirementsTo be successful in this role, you should have:
- A pragmatic mindset and be familiar with the operational aspects of clinical trials.
- Familiarity with the requirements of GCP.
- A bachelor's degree or master's degree in health, natural or information sciences, or have another relevant background and experience.
- High proficiency in English with strong communication skills.
- Hands-on experience with either maintenance or use of a Clinical Trial Management System (preferably Veeva) is considered a plus.
- Experience in implementing systems or procedures in clinical trials will also be considered a plus.
- You like working in systems and are curious about their extended possibilities.
- You have a can-do attitude to learn new things.
- You are structured, organized, and a proactive problem-solver.
- You are a team player who sees the goals of your colleagues as important for your tasks.
- You have a good technical flair and the motivation to teach others.
We are small enough to empower every individual yet powerful enough to drive transformative changes in the future of healthcare.
We are committed to pushing the boundaries of the world of clinical trials, ultimately accelerating the availability of new treatments for patients in need.
Be a part of Emply Denmark's journey and help us pave the way for a healthier future.
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