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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, including leading data management strategy, ensuring compliance with regulatory standards, and managing vendor relationships. Proficient in EDC systems and CDISC standards, with a strong focus on data quality and submission readiness.
Highest-signal resume keywords
Clinical Data Management StrategyCDISC Standards (CDASH, SDTM, ADaM)EDC/CDMS Platforms (Medidata Rave, Veeva Vault CDMS, Oracle InForm)FDA Regulations and ICH-GCP ComplianceCRO and Vendor Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Data ManagementDatabase Lock PlanningData Quality MetricsData Cleaning and ValidationRegulatory Submission PreparationRisk-Based Quality Management (RBQM)Statistical ProgrammingData Management PlanningSOP DevelopmentData Integration
Soft Skills
Excellent Communication SkillsAnalytical Problem-SolvingAttention to DetailOrganizational SkillsAbility to Work Under Pressure
Tools & Technologies
Medidata RaveVeeva Vault CDMSOracle InFormEDC SystemsClinical Data Management Systems
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRO IndustryNDA SubmissionBLA SubmissionMAA SubmissionFDAEMAGDPRHIPAA
Tech Stack
Tools & technologiesOracleVault
About the role
Key responsibilities & impact- Lead the strategy, build-out, and execution of clinical data management across the company’s clinical development portfolio
- Ensure data supporting global marketing authorization applications are complete, accurate, consistent, and submission-ready
- Own data management planning, EDC systems, data standards, database lock, and CRO/vendor oversight
- Build and lead a fit-for-purpose data management team and establish SOPs, systems, and governance
- Serve as senior data management leader and subject matter expert for marketing authorization application preparations
- Develop and execute clinical data management strategy across ongoing and planned trials
- Lead end-to-end database lock planning and execution for pivotal trials
- Represent data management in FDA and other regulatory authority interactions and respond to regulatory review information requests
- Partner with Regulatory Affairs and Biostatistics on submission data packages, including SDTM, ADaM, define.xml, and reviewer’s guides
- Oversee Data Management Plans, CRF/eCRF design, edit check specifications, and data validation plans
- Ensure data cleaning, query management, SAE reconciliation, coding, external data reconciliation, and third-party data integration
- Establish and monitor data quality metrics and drive continuous improvement
- Ensure adherence to CDISC standards and compliance with 21 CFR Part 11, GDPR/HIPAA, and data privacy and security policies
- Manage CRO, EDC vendor, and specialty data vendor relationships, including scope, budget, timelines, and quality oversight
- Lead vendor selection and oversee vendor audits and resolution of findings
- Ensure compliance with ICH-GCP, FDA regulations, and company SOPs; maintain inspection-ready documentation
- Lead readiness for pre-approval inspections and sponsor audits, including mock inspections and CAPA management
- Maintain SOPs, working practices, training materials, and training compliance
- Manage hybrid internal/outsourced operating model, function budget, resourcing, and vendor spend
- Partner with Biostatistics, Statistical Programming, Clinical Operations, Quality, Regulatory Affairs, Pharmacovigilance, and other functions
- Report progress and risks to senior leadership and, as appropriate, the Board
- Contribute as data management subject matter expert in cross-functional, alliance management, and business development activities
Requirements
What you’ll need- Advanced degree in life sciences, health informatics, statistics, computer science, or a related field; advanced degree preferred
- 12+ years of progressive clinical data management experience in the pharmaceutical, biotechnology, or CRO industry, including 5+ years in a senior leadership role
- Direct experience leading data management through at least one successful NDA, BLA, or MAA submission, including database lock and submission data package delivery
- Deep working knowledge of CDISC standards (CDASH, SDTM, ADaM) and experience ensuring submission-ready datasets
- Hands-on experience with major EDC/CDMS platforms such as Medidata Rave, Veeva Vault CDMS, and Oracle InForm/Clinical One
- Strong knowledge of FDA regulations, ICH-GCP, and 21 CFR Part 11 as applied to clinical data management
- Demonstrated success managing CROs and data management vendors, including budget and timeline accountability
- Experience supporting or leading through an FDA pre-approval inspection or comparable regulatory audit
- Experience in a small and/or mid-size clinical-stage biotech environment, including building a data management function and direct experience in US marketing authorization submission
- Therapeutic area experience relevant to Prilenia’s pipeline, such as neurology, rare disease, or CNS
- Experience with risk-based quality management (RBQM) and centralized statistical monitoring approaches
- Excellent knowledge of regulatory frameworks and requirements for data management, including FDA and EMA
- Familiarity with real-world data sources, patient registries, or external control arms
- Proficient in EDC/CDMS platforms
- Familiarity with the evolving role of AI and Computational Science as it relates to clinical and regulatory activities
- Excellent written and verbal communication skills, strong analytical and problem-solving abilities, strong attention to detail, ability to work independently and collaboratively, ability to meet deadlines and work under pressure, highly organized and self-motivated, flexibility to adapt to changing priorities, ability to work effectively in a global collaborative team environment, and strong interpersonal skills
Benefits
Comp & perks- Full-time remote position
- Flexible schedule
- Equal opportunity employment
- Diverse, inclusive, and welcoming workplace
- Up to 15% travel including CRO and site visits, investigator meetings, and regulatory interactions