Senior Clinical Programmer
il y a 6 jours
Our Mission
Our passion for improving patients' lives motivates us to apply our skills, experience and knowledge to advance medicine.
We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
The RoleWe are looking for a Senior Clinical Programmer to join our Biometrics Department where you will be responsible for timely and high-quality delivery of clinical data transformations and data reports/visualisations and datasets from multiple data sources to support ongoing data review to both internal and external consumers.
The Senior Clinical Programmer is team and quality focused and has the ability to influence other members of the project team to meet timelines and project goals, demonstrating a proven track record of effective relationship building with sponsors and colleagues, as well as strong time management skills.
Key Accountabilities- Take full ownership and management of timelines and quality for all assigned studies and flag potential problems to the Head of Department, Clinical Programming Team Lead and Project Manager, as appropriate.
- Attend Sponsor meetings, Kick-off Meetings and audits, to provide input from a Clinical programming perspective and to present the Clinical programming processes as required.
- Support Head of Department and Clinical Programming Team Lead in the review and update of SOPs and process improvement initiatives.
- Support the development of training and coaching and mentoring for colleagues.
- Act as point of contact for both internal and external customers for all Clinical programming tasks and issues for allocated studies.
- Develop specification documents and other supportive study documentation.
- Develop data transfer plans for 3rd party data.
- Manage the extraction of data from databases and create programs to manipulate the data into Simbec-Orion standard data structures using different systems and/or scripting languages.
- Program validation checks, reports/visualisations and listings to support clinical data management and review.
- Load electronic 3rd party data.
- Provide solutions to data issues that arise during the conduct and analysis of the study.
- Other relevant tasks as assigned by their manager with appropriate training.
ESSENTIAL
- Minimum A levels (or equivalent)
- Previous experience of clinical data programming within the pharmaceutical industry or a clinical research organisation
- Ability to understand clinical data structures and how to present data for data management/clinical review according to user requirements
- Experience of SAS Macros and/or similar scripting languages
- Experience of debugging SAS programs and/or similar scripting languages
- Excellent written and verbal communication skills in fluent English
- Excellent organisation and time management skills
- Excellent attention to detail, flexible, well-motivated
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
- Coaching and mentoring experience
- Experience of training and mentoring employees
- An understanding of clinical trial budgets
- Experience in identifying and tracking Out Of Scope activities
- Experience in Sponsor meetings including Kick-off Meetings and audits
- Ability to support process improvement activities
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to 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 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.
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