Senior EDC Developer

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 bachelors 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. Youll 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.

Remote Work :

Yes

Employment Type :

Full-time