Job Description

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient's lives.



The position is home based in India. Applicants must be eligible to work in India.

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

Role and Responsibilities

• Generates the eCRF application in terms of structure and data (entry) flow, based on given specification such as study protocol, available eCRF templates, etc.
• Creates edit checks specification with oversight from Project Data Manager and implements edit checks as part of the eCRF-application
• Implements/linking of LNR-related data with eCRF application during set-up and operational study phase
• Transferring/linking of external data into eCRF if applicable, including review of the DTA
• Implements/linking of data related to randomization with eCRF application
• Implements/linking of data related to IP Management with eCRF application
• Implements/linking of data related to ePRO/eCOA with eCRF application
• Creates IP management documentation for sites and IP shipper
• Act as unblinded programmer. Upload randomization schema and IP kit details on go-live and maintain during operational phase while preserving blinding.
• Performs all testing and validation tasks related to set-up and maintenance of eCRF application and processes
• Creates documentation (such as annotated CRF, implementation references etc.) as reference for the eCRF application.
• Generates validated data exports from the eCRF application
• Conduct user and site administration tasks
• Contribute to maintenance of EDC Template database
• Identify processes that will increase productivity, quality and efficiency
• Mentoring EDC developers

Qualifications

Graduate or bachelor's degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college

Relevant experience in a EDC development role managing multiple projects through the EDC set up and change control within the pharmaceutical industry, preferably at a CRO.

5+ years' experience in eCRF-build

Relevant experience in a EDC development role managing projects through the EDC set up and change control within the pharmaceutical industry, preferably at a CRO.

Effective communication skills

Cooperative and team-oriented approach

Self-motivation and ability to work independently

Supervision and training of junior staff in EDC build

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

We look forward to welcoming your application.