Sr. Clinical Data Manager

Responsibilities

• Provides oversight and accountability for data management activities and scientific data review across multiple trials.
• Makes recommendations and decisions that affect processes, timing, and structure for trials and assignments with minimal direction.
• Establishes, aligns, and confirms data management and clinical data management expectations with external suppliers, trial customers, and internal/external partners.
• Gathers and reviews content and integration requirements for eCRF and other data collection tools.
• Establishes conventions and quality expectations for clinical data and sets timelines for data management milestones.
• Affirms the accuracy of clinical data management documents and ensures compliance with regulatory guidelines and documentation requirements.
• Ensures real-time inspection readiness of all data management deliverables for trials; participates in regulatory agency and pharmaceutical internal audits.
• Identifies and communicates best practices and lessons learned at the trial level.
• Creates key functional plans (e.g., study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Participates in process, system, and tool improvement initiatives and leads others in implementing these improvements.
• Performs complex scientific study data review and management of CDM, Study Responsible Scientist (SRS), and Study Responsible Physician related queries in EDC system.
• Takes a leadership role in collaborating with SRS/SRP to ensure trial needs and deliverables are met.

Requirements

• Bachelor's or Master's degree required.
• 4+ years' experience in Pharmaceutical, CRO, Biotech, or Health-related fields or industries.
• Experience in clinical drug development within the pharmaceutical or related industry.
• Experience in clinical data review and knowledge of medical terminology.
• Strong written and verbal communication skills and team leadership experience (including cross-functional stakeholder engagement).
• In-depth knowledge of current clinical drug development processes, applicable international guidelines, and data management technologies.
• In-depth knowledge of project management and techniques.