Senior EDC Programmer

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Job description

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 the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

*Summary of the Position:*

We are looking for a Senior EDC Programmer to join our Biometrics department. You will be based remotely in the UK/EU.

You will act as the main point of contact for internal and external clients for all EDC Programming. You will carry out all aspects of EDC Programming from the EDC build and Edit Check programming processes and standards. You will provide support to the Principal Programmer or Programming Team Lead, with mentoring and training members of the department. You will ensure that departmental managers are kept fully informed of all project activities.

Key Accountabilities:

* Participate at face to face meetings, including Bid Defence Meetings, Kick-off Meetings, Sponsor Meetings and audits, to provide input from a Data Management EDC programming perspective and to present the EDC programming processes as required.
* Support department head and Programming Team Lead in the review and update of SOPs and process improvement initiatives.
* Provide in-house training and mentoring for colleagues.
* Act as point of contact for both internal and external customers for all Data Management EDC programming tasks and issues for allocated studies.
* Develop specification documents and other supportive study documentation.
* Work with lead data managers and Programming Team Lead to develop integrations with 3 rd Party Vendors.
* Manage the programming of EDC studies in line with the study specifications.
* Provide solutions to issues that arise during the conduct and analysis of the study.
* Manage the flow of work for allocated studies, adhere to agreed study timelines and flag potential problems to department head, Programming Team Lead and Project Manager, as appropriate.
* Other tasks as assigned by their manager with appropriate training.

* Minimum Requirements: *

* Essential: *

* Minimum A levels (or equivalent)
* Previous experience of EDC Programming within the Pharmaceutical industry or a clinical research organisation
* Experience of debugging EDC Issues
* Excellent written and verbal communication skills
* Excellent organisation and time management skills
* Excellent attention to detail, flexible, well-motivated
* A logical and analytical thinker
* Proactivity and risk management skills
* Fluent English

* Desirable: *

* A degree or equivalent in any science/maths subject or overseas equivalent
* Experience of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM)
* Experience of InForm EDC / Central Designer
* Experience of working on oncology and rare disease clinical trials
* Coaching and mentoring experience
* An understanding of clinical trial budgets
* Experience in Sponsor meetings including Kick-off Meetings and audits
* Ability to support process improvement activities

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. *