Principal Clinical Data Scientist- Data Management

📋 Description

• • Syneos Health is seeking a Principal Clinical Data Scientist specializing in Data Management to provide strategic and operational leadership for clinical data lifecycle management. This pivotal role ensures the integrity, quality, and usability of clinical data across complex studies, acting as a key functional lead within the Clinical Data Science team.
• • You will be instrumental in ensuring that all clinical data deliverables are not only fit for purpose but also strictly compliant with regulatory standards, contractual obligations, and sponsor expectations, all while adhering to critical study timelines.
• • This position demands a proactive approach to data quality, risk mitigation, and the implementation of innovative analytical solutions to accelerate the delivery of crucial clinical data milestones.
• • As the Data Management Functional Lead for Clinical Data Science, you will serve as the primary liaison between Clinical Data Science, Project Management, Clinical Monitoring, and other vital functional groups, fostering seamless collaboration.
• • A core responsibility involves developing comprehensive Data Management Plans, meticulously communicating data strategies, and adeptly troubleshooting and resolving complex data-related issues.
• • You will be empowered to recommend effective solutions and escalate any concerns that may impact patient safety, data integrity, or the accuracy of study analyses.
• • The role requires you to act as the central steward of clinical data quality, conducting holistic reviews of both clinical and operational data, leveraging your in-depth knowledge of protocols and therapeutic areas.
• • You will ensure that all required data elements and associated data quality oversight steps are precisely identified to support defined study analyses, guaranteeing the robustness of research outcomes.
• • Coordination of cross-functional data cleaning activities will be essential to meet stringent quality standards, project timelines, and contractual obligations, ensuring a high level of data accuracy.
• • You will develop Clinical Data Acquisition Plans and detailed data flow diagrams for intricate studies, ensuring alignment between data flow, study protocols, regulatory requirements, and study endpoints.
• • A key aspect of this role is assessing risks associated with protocol design, program-level strategies, and study parameters that could potentially impact data credibility and trial reliability, implementing proactive measures.
• • You will design and drive the development of advanced analytical tools and dashboards to proactively identify potentially unreliable or high-risk data, enhancing data monitoring capabilities.
• • Performing analytic reviews as defined in the scope of work and data acquisition plans will be crucial, including identifying root causes of data issues and implementing systematic, long-term resolutions.
• • You will be expected to demonstrate a thorough understanding of advanced technologies and critically assess their applicability to individual studies or broader programs, driving innovation.
• • Continuous monitoring and clear communication of project progress using status reports, tracking tools, and key metrics to Sponsors and internal teams will be vital for transparency and alignment.
• • Ensuring the successful launch, delivery, and completion of Clinical Data Science milestones in strict compliance with contracts, Standard Operating Procedures (SOPs), guidelines, and regulatory requirements is paramount.
• • You will be responsible for collecting and analyzing metrics to support and drive continuous process improvement initiatives within the Clinical Data Science function.
• • Reviewing and managing Clinical Data Science budgets, identifying any out-of-scope activities, and initiating change orders through Project Management will be part of your financial oversight.
• • Planning, managing, and allocating Clinical Data Science resources effectively, and coordinating the work of assigned team members will be critical for project success.
• • Developing and maintaining project plans, specifications, and all necessary documentation in strict compliance with SOP requirements is a fundamental duty.
• • Maintaining ongoing documentation and ensuring the completeness and accuracy of the Trial Master File (TMF) is essential for regulatory compliance and audit readiness.
• • You will actively participate in and present findings at internal, Sponsor, investigator, and third-party meetings, representing the Clinical Data Science function.
• • Contributing to proposals, bid defenses, and RFP responses, and actively promoting new Clinical Data Science business opportunities aligned with Sponsor strategies will support business growth.
• • Preparing documentation for and participating in internal and external audits will require meticulous attention to detail and a strong understanding of compliance requirements.
• • You will be expected to train and mentor junior team members, fostering their development and ensuring knowledge transfer within the team.
• • Maintaining proficiency in Clinical Data Science systems through ongoing training and professional development is a continuous requirement of the role.
• • Performing other duties as assigned will ensure flexibility and comprehensive support across the team and organization.