About this role
Company Description
Medicine moves forward here. So will you.
Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.
Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.
The position is also available in any of our European locations
Job Description
ROLE AND RESPONSIBILITIES
- Create and maintain CDASH compliant eCRF template library and all related supplementary documentation
- Act as Subject Matter Expert (SME), providing technical oversight, support, training and guidance for Sponsors and Ergomed clinical and BD teams as required
- Assist with system validation activities and documentation in support of BSO/TSO as required
- Creates and reviews EDC system in terms of adherence to structure, workflow, edit checks and user roles & permissions; based on data standards (CDASH), study protocol and standard eCRF templates
- Ensures that the correct stakeholders are involved in the overall compliance in EDC creation and adherence to timelines. Including, but not limited to, Sponsor, Clinical Operations, Medical Monitor, Biostatistician and Biostatistical Programmer.
- Uses programming language (SAS, SQL, Python, Power BI) to data listings, reports, quality checks, dashboards, and metrics to support data review, reconciliation, and project oversight.
- Oversees the creation of all study level documentation related to EDC System
- Provides technical oversight, training, support and guidance to study team and sponsor throughout study lifecycle
- Supports and performs gap analysis for EDC systems not created by Ergomed
- Oversees and provides technical guidance and oversight for data migrations
- Co-ordinating with external vendors, e.g. central labs, regarding format and mechanism of transferred/imported data.
- Understands coding dictionaries, including version updates and licensing; general understanding of the coding process for WHO Drug and MedDRA. Oversee bi-annual coding dictionary upgrade process
- Oversees and performs post-live changes to EDC system
- Oversees and performs site and user account management tasks, including record maintenance and periodic review
Qualifications
- Medidata RAVE and Zelta v1.0 experience is essential
- Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college
- Advanced proficiency in data systems, including accreditation in at least one clinical trial EDC system (Zelta, Medidata Rave etc.).
- Experience in EDC system creation and Edit Check programming
- Proficiency in data standards (CDASH & SDTM) and application to EDC system creation, CDASH Certification preferred
- Effective communication skills
- Cooperative and team-oriented approach
- Self-motivation and ability to work independently
Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.