As part of Novotech’ s Biometrics unit, the Senior Validation Specialist (SVS) is responsible for all validation activities related to Data Management systems and processes. The SVC acts as primary point of contact for all validation matters to the study team and is responsible for the timely delivery of quality outputs following all applicable regulatory, compliance, best practice and operational procedures.
Minimum Qualifications & Experience:
Graduate in information science or life science related field, or similar. More than four years’ experience in a Senior Clinical Data Programmer/Validation role in a pharmaceutical company, CRO or EDC software provider.
Responsibilities:
The Senior Validation Specialist (SVS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the validation team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team.
• Scope validation effort for projects and project manage all validation activities across multiple projects.
• Maintain validation documentation within project files as appropriate.
• Create and update DB Validation plans, Edit Check test plans and other study test plans as required per protocol.
• Undertake quality reviews and testing activities.
• Generate and review status reports and metrics as appropriate. Identify and communicate project risks.
• Represent validation group at internal / external meetings as appropriate.
• Assess and implement new testing processes and technologies.
• Take an active role in the development of best practices, process improvement, quality control and governance related to all validation matters.
• Provide training and mentoring to Validation team members in SOPs, software applications, and best practices.
• Provide Subject Matter Expertise on all validation and testing related activities.
Attributes and Skills
Expert knowledge of System Development Life Cycle (SDLC) methodology. Expert domain knowledge and experience within clinical research and drug development. Advanced programming knowledge in >1 EDC systems and familiarity with test automation technologies. Experience mentoring and training others. Awareness of regulatory and compliance issues and understanding of application of SOPs and
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