Jobgether
Accountabilities:: Serve as the lead data manager for assigned clinical studies and programs, establishing study-specific data management strategies, timelines, and deliverables. Review and approve key documentation, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation. Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, reports, and listings. Plan, execute, and document testing of database builds, eCRFs, edit checks, derivations, and system functionality, including defect assessment, resolution tracking, and UAT retesting. Lead data review, query management, external data reconciliation, and database lock activities while overseeing CRO and vendor deliverables. Monitor data quality, study metrics, and timelines to identify risks early and support external data integrations, transfer specifications, reconciliation, and inspection readiness. Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, CROs, and external vendors to communicate progress, risks, decisions, and timelines. Review CRO financial reports, change notifications, and data management expenses to support scope, budget, and timeline management. Build productive relationships across internal teams and external partners, navigating challenging situations with professionalism and a solutions-oriented mindset. Identify opportunities to improve data management processes, standards, tools, and templates, and share best practices across clinical programs. Ensure day-to-day decisions align with study priorities, patient safety, data quality, compliance requirements, and broader program objectives. Requirements: Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred. 7+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry. Hands-on experience with Medidata Rave EDC, eCOA, and RTSM. Demonstrated ability to create, run, review, and interpret Medidata Rave reports and listings for data review, cleaning, reconciliation, and oversight. Experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting. Strong understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes. Strong knowledge of ICH-GCP and applicable clinical research regulatory requirements. Experience reviewing CRO study finance reports, change notifications, and data management expenses. Excellent written, verbal, and interpersonal communication skills, with the ability to work effectively with both technical and non-technical stakeholders. Strong organizational and prioritization skills, with the ability to manage multiple studies, competing deadlines, changing requirements, and time-sensitive deliverables. Demonstrated ownership, accountability, follow-through, and attention to detail across study deliverables. Ability to operate effectively in a fast-paced, high-pressure environment while maintaining quality, compliance, and sound judgment. Strong problem-solving and risk-management skills, with the ability to make timely, risk-based decisions in ambiguous situations. Ability to influence stakeholders and drive accountability across internal teams and external partners without direct authority. Familiarity with Spotfire or similar data visualization and analytics tools is preferred. Experience in a small to mid-sized biotechnology environment is preferred. Familiarity with CDISC standards, risk-based data review methodologies, and external vendor data integrations is a plus. Benefits: Base salary range of $140,000–$196,000 per year. Annual bonus eligibility. Equity compensation. Competitive benefits package. Opportunity to lead clinical data management activities across clinical-stage programs. Cross-functional collaboration with clinical, statistical, medical, safety, and external development teams. Opportunity to contribute to data management process improvements, standards, tools, and operational excellence. Environment focused on patient-centered execution, data quality, compliance, and innovation. Opportunity to work within a growing biotechnology organization advancing AI-enabled approaches to drug design and development. Equal employment opportunity and an inclusive workplace that values diverse perspectives and backgrounds. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1