Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Main Duties and Responsibilities:

We are looking for a Senior EDC Programmer to join our Biometrics department. This role will be based remotely in Hungary.

As The Senior Senior EDC Programmer you will perform Electronic Data Capture (EDC) programming in accordance with Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs), ICH-GCP and Scope of Work within agreed study timelines. You will be the main point of contact for internal and external clients for all programming related issues on the allocated studies and will provide training and mentoring to colleagues.

You will also participate in Kick-off and Sponsor meetings and will be involved in audits.

Minimum Requirements:

Essential:

• Previous experience of InForm EDC Programming within the pharmaceutical industry or a clinical research organisation
• Experience of debugging EDC Issues
• Coaching and mentoring experience
• Ability to support process improvement activities
• Excellent written and verbal communication skills and fluent in English
• Excellent organisation and time management skills

Desirable:

• A degree or equivalent in any science/maths subject
• Experience of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM)
• Experience of working on oncology and rare disease clinical trials
• An understanding of clinical trial budgets
• Experience in Sponsor meetings including Kick-off Meetings and audits
• Experience in Bid Defence Meetings, including preparatory and follow up meetings
• Previous experience with resource planning and task allocation
  

Simbec-Orion Job Profile - Senior EDC Programmer.pdf

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.