Vice President, Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Spearhead the strategy, development, and implementation of clinical data management across the organization’s clinical development portfolio.

• Guarantee that data supporting global marketing authorization submissions are thorough, precise, consistent, and ready for submission.

• Take ownership of data management planning, EDC systems, data standards, database locking, and oversight of CRO/vendor activities.

• Build and manage a data management team that is fit for purpose, while establishing SOPs, systems, and governance frameworks.

• Act as a senior leader in data management and a subject matter expert for preparations related to marketing authorization applications.

• Formulate and implement the clinical data management strategy for both ongoing and upcoming trials.

• Direct the planning and execution of end-to-end database locking for pivotal trials.

• Represent data management in interactions with the FDA and other regulatory authorities, addressing information requests during regulatory reviews.

• Collaborate with Regulatory Affairs and Biostatistics on submission data packages, which include SDTM, ADaM, define.xml, and reviewer’s guides.

• Supervise Data Management Plans, CRF/eCRF design, edit check specifications, and data validation strategies.

• Ensure thorough data cleaning, query management, SAE reconciliation, coding, reconciliation of external data, and integration of third-party data.

• Establish and track data quality metrics while promoting continuous improvement initiatives.

• Ensure compliance with CDISC standards and adherence to 21 CFR Part 11, GDPR/HIPAA, as well as data privacy and security policies.

• Manage relationships with CROs, EDC vendors, and specialized data vendors, including oversight of scope, budget, timelines, and quality.

• Lead the selection of vendors and supervise vendor audits as well as the resolution of any findings.

• Ensure compliance with ICH-GCP, FDA regulations, and company SOPs while maintaining documentation that is ready for inspection.

• Prepare for pre-approval inspections and sponsor audits, including conducting mock inspections and managing CAPA.

• Maintain SOPs, working practices, training materials, and ensure training compliance.

• Oversee a hybrid internal/outsourced operational model, manage the function budget, resource allocation, and vendor expenditures.

• Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Quality, Regulatory Affairs, Pharmacovigilance, and other departments.

• Report on progress and risks to senior leadership and, when appropriate, the Board.

• Contribute as a subject matter expert in data management for cross-functional initiatives, alliance management, and business development efforts.

⛳️ Requirements

• Advanced degree in life sciences, health informatics, statistics, computer science, or a related discipline; advanced degree is preferred.

• Minimum of 12 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO sectors, including at least 5 years in a senior leadership position.

• Direct experience in leading data management for at least one successful NDA, BLA, or MAA submission, encompassing database locking and delivery of submission data packages.

• Extensive working knowledge of CDISC standards (CDASH, SDTM, ADaM) and experience in ensuring datasets are submission-ready.

• Practical experience with major EDC/CDMS platforms such as Medidata Rave, Veeva Vault CDMS, and Oracle InForm/Clinical One.

• Strong understanding of FDA regulations, ICH-GCP, and 21 CFR Part 11 as they pertain to clinical data management.

• Proven success in managing CROs and data management vendors, with accountability for budget and timelines.

• Experience supporting or leading during an FDA pre-approval inspection or similar regulatory audit.

• Background in a small to mid-sized clinical-stage biotech environment, including the establishment of a data management function and firsthand experience with US marketing authorization submissions.

• Relevant therapeutic area experience aligned with Prilenia’s pipeline, such as neurology, rare diseases, or CNS.

• Familiarity with risk-based quality management (RBQM) and centralized statistical monitoring methodologies.

• Comprehensive knowledge of regulatory frameworks and data management requirements, including FDA and EMA regulations.

• Awareness of real-world data sources, patient registries, or external control arms.

• Proficiency in EDC/CDMS platforms.

• Understanding of the evolving impact of AI and Computational Science on clinical and regulatory activities.

• Exceptional written and verbal communication skills, along with strong analytical and problem-solving capabilities, meticulous attention to detail, and the ability to work independently and collaboratively. Must be well-organized, self-motivated, adaptable to changing priorities, able to meet deadlines under pressure, and exhibit strong interpersonal skills.

🏝️ Benefits

• Full-time remote position.

• Flexible work schedule.

• Equal employment opportunity.

• A diverse, inclusive, and welcoming workplace.

• Up to 15% travel for CRO and site visits, investigator meetings, and regulatory interactions.