Executive Director, Clinical Data Management

Kardigan • Princeton, NJ

8d • $258,000 - $336,000 • Onsite

About The Position

The Executive Director, Clinical Data Management, leads the strategic and operational direction of the Clinical Data Management function across the clinical development portfolio at Kardigan. Operating in a lean, faced-paced environment, the incumbent will lead the acquisition, management, and delivery of clinical data across all clinical programs and actively contribute to the clinical and regulatory strategy and submissions. Reporting to the VP of Biometrics, this role is a member of the Biometrics leadership team, and, as such, contributes to key initiatives and enterprise level projects.

Requirements

• Bachelor’s degree required. Advanced degree preferred (MS, PhD, MD, MPH) in Life Sciences, Data Science, Biomedical Engineering, Informatics, or related field.
• 12+ years of experience in Clinical Data Management, Clinical Operations or Biometrics within biopharma, biotech, CRO, or health technology. Or 10+ years with an advanced degree
• Experience leading teams across multiple locations and geographic regions preferred
• Extensive experience in drug development and working with regulatory agencies such as FDA and EMA
• Proficiency in CDISC requirements for regulatory submissions, including expertise with preparation and submission of data in CDISC - STDM/ADaM, CDASH
• Strong understanding of EDC systems, data standards, and end-to-end data management processes and governing regulatory expectations (ICH, 21CFR Part 11)
• Experience managing non-EDC data sourced (e.g laboratory data, imaging data, ePRO, IRT and other sources)
• Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
• Excellent collaborator, communicator (verbal & written), and influencer across technical and non-technical audiences
• Detail and process oriented and demonstration of strong project management skills. Exhibits expertise in metrics analysis and reporting methodologies.

Nice To Haves

• Advanced training or certification in clinical research and/or data management relevant disciplines (PMP, CCDM, etc.)
• Prior experience working in smaller, fast-paced company
• Demonstrated success in leading high-performing, multidisciplinary teams

Responsibilities

• Set vision, oversee and direct the clinical data management function, including design and implementation of the clinical data management process, vendor selection & oversight, clinical systems design and validation, user acceptance testing, data integration and quality, data review, dictionary coding, data transfer, reporting, and archival activities for EDC, IRT, and other clinical systems
• Oversee integrated data strategies across programs and trials to ensure delivery of quality, inspection-ready datasets
• Develop and oversee key performance indicators, ensure continuous improvement, and risk & issue management
• Oversight of financial forecasting, budget, and expense management
• Ensure that all submitted data and information follow regulations (eg, ICH E6/E9, 21 CFR Part 11, GCP) and global data standards & regulatory requirements for NDA/BLA submission
• Serve as a liaison between Development, Regulatory, Pharmacovigilance, Research, IT, other stakeholders to ensure that data related business requirements are clearly defined, communicated, well understood, and considered as part of operational efficiency and strategic planning
• Champion modern automation and data visualization tools to improve efficiency and data quality
• Oversee standards for data acquisition, CDISC/CDASH compliance, data cleaning, query resolution, and overall data quality ready for regulatory submission
• Drive the selection and optimization of data systems (eg, EDC, data repositories) and scalable governance & SOP for data flow, data integrity, and oversight of CRO/vendor deliverables
• Design a future state clinical data management function transforming into an automated and ‘real time’ data function and reducing site & patient burden
• Drive the organization’s data-driven culture, enabling rapid, high-quality decision making through analytics and innovative data solutions
• Assess and transform capabilities through AI and Automation solutions or strategies with a focus on real-time data strategies to enable decision-making
• Establish best practices, SOPs, and governance frameworks for data flow across programs
• Conduct resource forecasting and talent development including training, mentoring, goal setting, performance management and engagement
• Lead or support the Health Authority inspections and audits as related to Data Management activities
• Up to 20 – 30% domestic and international travel as required

What This Job Offers

• Job Type: Full-time
• Career Level: Director