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Publicis Sapient is a digital transformation partner helping established organizations get to their future, digitally-enabled state, both in the way they work and the way they serve their customers. We help unlock value through a start-up mindset and modern methods, fusing strategy, consulting and customer experience with agile engineering and problem-solving creativity. United by our core values and our purpose of helping people thrive in the brave pursuit of next, our 20,000+ people in 53 offices around the world combine experience across technology, data sciences, consulting and customer obsession to accelerate our clients’ businesses through designing the products and services their customers truly value.

Clinical Data Management Lead Overview:

We are seeking a Clinical Data Management Lead with over 10 years of experience leading diverse teams on Federal IT and/or Research contracts and a deep understanding of bioinformatics platforms supporting research studies. The ideal candidate will have experience leading and managing teams supporting and assisting researchers in sharing, accessing, and analyzing biomedical research data in large data repositories, including, adherence to data stewardship best practices and data sharing policies and processes. Candidates should understand how IT systems can facilitate secure data ingestion, curation, annotation, integration, analysis, and sharing across multidisciplinary research teams.

• Leverage biomedical research and research data lifecycle management expertise to lead management and curation of primary clinical research data to support secondary use; this includes providing subject matter expertise to guide researchers through the data submission process, including dataset:

• Curation,
• Harmonization,
• Aggregation,
• Deidentification,
• Standardization,
• Data dictionary management, and
• Interoperability of clinical data and metadata

• Assess and monitor research data quality within the data submission lifecycle.
• Onboarding of research teams/collaborators for data submission into research data management system and educating/guiding them on policies and processes as well as providing training
• Monitors progress against incoming deliveries of data into data management system and provides status to clients using project/program management tools and techniques to organize, plan, track, coordinate, execute, report, and evaluate program projects, objectives, and status reports
• Responsible for analyzing potential complex data management issues/risks and recommending/implementing solutions
• Advocates for primary stakeholder needs, works with other program teams to compromise on solutions and participates in change management / end users and governance activities
• Communicate and liaise between the IT team and client to ensure mutual understanding with regards to protocol workflow, technical requirements, timelines, system functionality, system capabilities, and new product features
• Provides oversight of training documentation and system user access, may serve as resource for complex troubleshooting
• Leads or actively participates in internal and external calls/meetings/working groups and documents and follows up on action items
• Authors, reviews, and/or edits written reports presenting the results, interpretations, conclusions, and impact analysis
• May be required to facilitate or present at scientific meetings, conferences, and other events
• Provides technical guidance to a wide user audience to include training on use and interpretation of data resources (including updates and changes)
• Creates, plans and directs instructional sessions and workshops
• Defines/updates documentation to maintain the quality of data resources
• Coaches and mentors junior team members

• Preferred Bachelor’s or Master’s in scientific discipline accompanied with advanced understanding of the clinical development and data lifecycle management processes
• Over 10 years of relevant work experience in a related field - life sciences, health programs, clinical research, NIH or other related government health research programs, etc.
• Understanding of biomedical research datasets (e.g., including research administration, survey, imaging, genomics) and data standards
• Familiarity with collecting, analyzing, and interpreting clinical data (e.g., large datasets, metadata) for research purposes and/or to help drive decision-making
• Experience in developing and proactively managing comprehensive Standard Operating Procedures (SOPs)
• Hands on experience managing data life cycle of clinical data and familiarity with related data standards
• Excellent analytical and organizational skills, including the proven ability to adapt to a dynamic project environment
• Strong skills in prioritization, organization, problem-solving, decision-making, time management, mentoring and planning
• Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity
• Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues
• Experience establishing and maintaining effective harmonious relationships with diverse technical and non-technical groups
• Experience with providing analysis and support to science and technology programs
• Understanding of the needs and workflows of researchers and scientific staff in federal research environments.
• Personnel management and project team leadership experience highly desired
• Proficient with collaboration tools including Atlassian Jira and Confluence, and Microsoft Office applications-MS Office, Excel, Word, Visio, and PowerPoint
• Experience working with Agile delivery methods like Scrum and Kanban
• Must be a U.S. Citizen or U.S. Legal Permanent Resident
• Eligible for U.S. Government Clearance