Original listing text, shown exactly as published by the company.
Key Responsibilities
- Systems & Technology Leadership
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- Provide strategic and operational leadership for DM systems (e.g., EDC, ePRO/eCOA, RTSM, CTMS integrations).
- Lead selection, implementation, optimization, and governance of DM technologies and platforms to support scalable, high-quality data management across clinical development programs.
- Champion data standards (e.g., CDISC, SDTM) and metadata-driven approaches.
- Partner with Biostatistics, Programming, and IT to ensure seamless data flow and interoperability across systems.
- Evaluate emerging technologies (AI/ML, automation, decentralized trial tools) to enhance data quality and efficiency.
- Program & Study Leadership
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- Provide strategic leadership and oversight of DM activities across assigned clinical programs (Phases I–III and beyond).
- Serve as the DM lead on cross-functional program teams, influencing study design, timelines, and data strategy.
- Ensure delivery of high-quality, submission-ready datasets in alignment with program milestones.
- Proactively identify risks to data quality, timelines, or deliverables and implement mitigation strategies.
- Data Management Operations
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- Oversee all DM deliverables including CRF design, database build, data cleaning, coding, and database lock.
- Establish and maintain data review strategies, including centralized monitoring and risk-based approaches.
- Ensure compliance with GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.).
- Drive inspection readiness and support regulatory submissions.
- Vendor & Partner Oversight
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- Provide strategic oversight of CROs and external data vendors.
- Define scope, KPIs, and performance metrics; ensure accountability and high-quality deliverables.
- Lead vendor selection and contract input for DM-related services.
- People Leadership & Development
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- Build, mentor, and lead a high-performing DM team.
- Foster a culture of accountability, innovation, and continuous improvement.
- Provide coaching and career development for team members.
- Process Improvement & Innovation
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- Develop and standardize DM processes, SOPs, and best practices.
- Drive initiatives to improve efficiency, scalability, and data quality.
- Lead or contribute to cross-functional initiatives related to data strategy and digital transformation.
Ideal Candidate
- Bachelor’s degree in life sciences, computer science, or related field; advanced degree preferred.
- 12+ years of experience in clinical data management within biotech, pharma, or CRO environments.
- Experience in both operational DM and systems/technology implementation.
- Demonstrated leadership of DM activities across multiple clinical trials and programs.
- Technical Expertise
- Deep knowledge of EDC systems (e.g., Medidata Rave).
- Strong understanding of CDISC standards (SDTM, CDASH) and data lifecycle.
- Experience with data integrations, external data (labs, imaging, biomarkers), and decentralized trial technologies.
- Familiarity with data visualization and analytics tools is a plus.
- Leadership & Competencies
- Proven ability to lead cross-functional teams and influence at the program level.
- Strong strategic thinking with hands-on execution capability.
- Excellent communication and stakeholder management skills.
- Experience in fast-paced, growing organizations preferred.
- Ability to bridge systems/technology with clinical execution.
- Strong ownership mindset over data quality and delivery timelines.
- Proactive, solutions-oriented approach to complex data challenges.
- Effective leadership in ambiguity and evolving clinical landscapes.
The anticipated salary range for candidates for this role will be $215,000 - $245,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
