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Senior Clinical Programmer
2 months ago
We are seeking a highly skilled Senior Clinical Programmer to join our Global Data Management team in the UK. As a key member of our team, you will be responsible for providing database development services to our clients in the pharmaceutical industry.
Main Responsibilities:- Lead Clinical Programmer: Act as the lead programmer for one or multiple studies, ensuring timely delivery and high-quality results.
- Clinical Programmer Tasks: Complete clinical programmer tasks for assigned studies under minimal supervision, adhering to study contracts and applicable SOPs.
- Database Development: Design, develop, implement, maintain, and support clinical database systems, ensuring they meet the required standards and regulations.
- Technical Expertise: Offer technical expertise to internal and external clients, providing guidance on database development and maintenance.
- Database Manipulation: Code, test, and document databases according to programming standards and clinical validation policies.
- Data Transfers: Program database manipulation and conduct data transfers for clients, ensuring seamless data exchange.
- Data Validation: Review Data Validation Plans and Case Report Forms, utilizing your area of expertise to ensure accuracy and compliance.
- External Data Integration: Add external data sources, such as PK and central lab data, to the clinical database if integration is requested or required.
- Programming Contact: Serve as the primary contact for database issues within your area of expertise, providing timely resolutions.
- Technology Support: Support the development and implementation of new technologies, ensuring they align with our company's goals and objectives.
- Change Control: Support Information Technology in evaluating new technology upgrades, participating in software change controls to ensure seamless integration.
- Procedure Development: Support the development, revision, and maintenance of core operating procedures and working instructions related to database development, user acceptance testing, and change controls.
- Team Collaboration: Interface with project teams to organize responsibilities and deliverables, ensuring effective communication and collaboration.
- Communication: Establish and maintain effective communication and professional relationships with teams and external vendors.
- Timeline Negotiation: Interface with Clinical Data Management and corporate teams to negotiate timelines, ensuring project deliverables are met.
- Administrative Tasks: Perform administrative tasks within the EDC system, such as site and user management, URL level reviews and/or approvals, and dictionary updates.
- Data Standards: Follow and influence the development of data standards and strategies pertaining to the standards library.
- Regulatory Knowledge: Understanding of the principles of ICH GCP and regulatory requirements is essential.
- RAVE EDC Experience: RAVE EDC build experience is essential for this role.
- Organizational and Analytical Skills: Excellent organizational and analytical skills, strong oral and written communication skills, and the ability to work in a high-paced, timeline-driven setting.
- Education: Minimum BS in a scientific or health-related field or equivalent in years of experience.
- Previous Experience: Previous experience as a clinical database developer with at least one year of experience leading a study build.
