Senior Clinical Data Management-Consultant

We are seeking a highly skilled and strategic Clinical Data Management Consultant to establish and create the leadership structure for our new data management department. This pivotal role requires an experienced leader who can design and execute a comprehensive data strategy while also being comfortable with hands-on, day-to-day data management tasks. The ideal Consultant will build the department from the ground up, implementing data governance, quality, and architecture standards to transform our data into a strategic asset. The primary responsibilities of the Consulting role will entail managing our clinical trial and translational data. The ideal Consultant should have extensive knowledge of the clinical data management principles, regulatory guidelines, and industry best practices. They should be willing to work independently and collaboratively with cross-functional teams to ensure timely and accurate data delivery.

• Department building and strategic leadership:
• Establish the clinical DM department. Initially operating as individual consultant to oversee clinical data management activities outsourced to one or more clinical CROs.
• Develop clinical data strategy and roadmap: Work with cross-functional stakeholders (e.g., clinical development, clinical operations, translational science) to define the clinical data strategy.
• Implement clinical data governance framework: Design and enforce a comprehensive clinical data governance framework with clear policies, procedures, and standards for data usage, security, and quality.
• Create and enforce clinical data quality standards: Define and measure clinical data quality metrics, establishing processes to continuously monitor, cleanse, and validate clinical data. Identify and resolve root causes of clinical data quality issues.
• Manage clinical data lifecycle: Oversee clinical data archiving and destruction as required, ensuring compliance with clinical data management standards.
• Support periodic reconciliation of Translational specimen inventory across systems (EDC, Central and Specialty lab inventories) to confirm data integrity and sample traceability.
• Day-to-day management and technical execution:
• Oversee clinical data architecture: Design and maintain the clinical organization's overall data architecture, including databases, data warehouses, and data lakes. Ensure systems are optimized for performance, scalability, and security.
• Manage clinical data integration and pipelines
• Hands-on data operations: Perform day-to-day clinical data management tasks such as querying, and managing clinical database performance, backups, and recovery operations.
• Lead end to end clinical data management activities for clinical trials from start through database lock
• Oversee clinical database design, CRF annotation and UAT of EDC
• Partner with Translational Sciences to support clinical data from central and specialty labs: DTA generation, data ingestion, cleaning and reconciliation

• Educational background: Bachelor's degree
• 8+ years of progressive experience in clinical data management, with a proven track record of leadership in a similar role.
• Certification in clinical data management (like CCDM).
• Knowledge of CRF design, MS Project or similar and analytical capabilities.
• Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
• Understanding of data privacy and protection regulations (e.g., GDPR).
• Strategic and analytical mindset: Ability to translate abstract business concepts into tangible data strategies.
• Exceptional communication skills: Strong written and verbal communication skills to effectively convey complex data concepts to both technical and non-technical stakeholders.
• Problem-solving and adaptability: Proactive approach to identifying and solving complex data challenges, with the ability to navigate ambiguity and change.
• Collaboration: Strong interpersonal skills to build relationships and collaborate effectively across diverse team