EDC Developer (Medidata RAVE and Zelta v1.0)

Ergomed; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Ergomed Group is seeking an EDC Developer to join the Data Management team in Madrid. You will build and configure the EDC application for complex projects, ensuring data standards and study templates are applied.

Responsibilities include creating EDC structure, randomisation, ePRO, IMP management and targeted SDV, plus documenting specifications and training materials. You will collaborate with cross-functional teams across Europe.

Formación

• Graduate or bachelor’s degree in Life Sciences (or Pharma or related health discipline)
• Prior experience in EDC system creation and Edit Check programming is a must
• Proficiency in data standards (CDASH & SDTM) and application to EDC system creation

Responsabilidades

• Creates EDC system in terms of structure, workflow, edit checks and user roles & permissions; based on data standards (CDASH), study protocol and standard eCRF templates.
• Creates all study level documentation related to EDC System, including, but not limited to specifications, test plans, study specific training materials; performs post-live changes under Change Control process
• Role includes Medidata RAVE and Zelta v1.0 experience is essential
• Cooperative and team-oriented approach; self-motivation and ability to work independently

Conocimientos

Medidata RAVE

Zelta v1.0

EDC development

Edit Check programming

CDASH data standards

Educación

Bachelor's degree Life Sciences or Pharma

Herramientas

Medidata RAVE

Zelta v1.0

Descripción del empleo

EDC Developer (Medidata RAVE and Zelta v1.0)

• Full-time
• Department: Data Management

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

The EDC Developer within the ERGOMED Data Management (DM) department is responsible for all tasks linked to the building of the EDC application forcomplex projects. The EDC Developer represents a position under direction of the Director of Data Management, with oversight by the Project Data Manager on a project level.

ROLE AND RESPONSIBILITIES

• Creates EDC system in terms of structure, workflow, edit checks and user roles & permissions; based on data standards (CDASH), study protocol and standard eCRF templates. Including, where applicable:
• Randomisation
• ePRO (including licensing, validation & translation)
• IMP Management
• Targeted SDV
• Any other additional (non-core) EDC functionality

Creates all study level documentation related to EDC System, including, but not limited to:

• Specifications
• Test Plans
• Study specific training materials
• Performs post-live changes to EDC system and applicable reporting applications under Change Control process

• 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
• Prior experience in EDC system creation and Edit Check programming is a must
• Cooperative and team-oriented approach
• Self-motivation and ability to work independently
• Proficiency in data standards (CDASH & SDTM) and application to EDC system creation, CDASH Certification preferred

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.

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