Programmer Analyst

Job description

Details:
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies. An opportunity has arisen in within the Clinical Data Acquisition and Delivery group to support the Clinical Pharmacology domain. We are looking for an enthusiastic and innovative individual to join our team, who will provide programming support and drive the technical strategies for clinical studies.

In addition to the supporting the oversight and acquisition of data, key accountabilities will also include the development of validated programs that support the collection, extraction and integration of clinical data for GSK's Cambridge based clinical pharmacology unit (CUC), oversight of SDTM deliverables from CROs, and day-to-day technical programming support for clinical project teams.

** Please note these are project / process / stakeholder / 3 party management positions not fully hands on programmer roles - as such they are the next step for candidates with prior backgrounds in programming who want to further develop their careers within project management. **

Remote opportunity may be considered.

Responsibilities include, but are not limited to:
• Global internal and external expert for complex data management and data quality considerations. May be recognized as a global technical/business leader. Regularly provides expertise to others within and outside GSK.
• Contribute to the technical strategy and delivery for global clinical project levels. Includes working with representatives from multiple project teams, including clinical data standards, statistics and programming, and laboratory staff.
• Provide technical input to protocol and other plans at the development phase of a study, ensuring compliance with ICH-GCP and effective data collection practices.
• Coach and mentor colleagues with advanced programming tasks.
• Provide Input to the strategic delivery plan for data capture tools across the studies of a clinical development program.
• Provide input to the development of data capture tools for a clinical study, including the eCRF and ePRO.
• Ensures data programming procedure are of the highest quality and are audit ready
• Lead role in developing strategic programming partnerships.
• Participates in due diligence activities and risk assessments with specific emphasis on the programming and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships.
• Lead role in the management of the data vendor deliverables and performance.
• Subject Matter Expert for the Data Quality Community bringing programming expertise, which would include expert input into to and the development, implementation and communication of programming control documents.
• Oversees CDISC/SDTM conversions with both internal and external partners.

Please indicate within a cover letter if you are confirmed as displaced (or potentially displaced) and at risk of redundancy.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
• Bachelors Degree or higher in mathematics, statistics, computer science or related discipline
• Knowledge of multiple programming languages – including PL/SQL, SAS, Python, C#
• Experience working with complex clinical data, such as Biomarkers, Flow Cytometry, and novel data collection technologies (i.e. wearable technology)
• Solid understanding and experience of working with CDISC SDTM

This position is open at various grade levels, based on experience.

Additional minimum qualifications for Grade 6:
• Significant prior supervisory experience.
• Experience in leading and developing teams.
• Ability to influence others and motivate teams
• Demonstrated leadership of cross-functional or matrix teams.
• Experience with developing collaborative relationships with both internal and external teams.

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Preferred qualifications:
• Experience with developing, validating, and maintaining clinical trials built in several EDC platforms, including but not limited to Oracle Clinical or Inform (Central Designer)
• Experience with evaluating electronic data collection systems to determine feasibility and best fit against project requirements.
• Experience working in database systems and environments, including Oracle and Unix
• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP and CFR21 Part 11).
• Experience with integrating multiple complex clinical study data throughout the entire study lifecycle, from protocol development through database lock.
• Experience of working with and overseeing the delivery of clinical data from external companies
• Ability to manage conflicting demands and priorities
• Experience interacting with project teams and laboratory staff and working in a matrix environment
• Effective written and verbal communication skills
• Ability to explain complex technical principles to non-technical staff.