Head of Data Management; Senior Director

Head of Data Management (Senior Director) Position Summary

Reports to: Head of Clinical Development Operations (for now)
Location:Basel or Boston Area

Supervises: Data Management Leads (Directors or ADs) and Managers (FTEs or contractors)

• The Head of Clinical Data Management (Senior Director) is a functional leader within Noema Pharma, a fast growing biotech organization, responsible for establishing and driving the company’s data management strategy, infrastructure, and execution across all current and future clinical programs. This role is both strategic and hands on, ideal for a leader who thrives in a dynamic, resource lean biotech environment where flexibility, cross functional partnership, and operational excellence are essential.
• The Head of Clinical Data Management (Senior Director) oversees internal and outsourced data management activities, ensures data integrity across early and late phase clinical studies, and helps build the clinical data foundation required for regulatory submissions and rapid pipeline progression.

• Strategic Leadership
  • Develop and execute the CDM strategy aligned with Noema’s clinical development portfolio and corporate objectives.
  • Establish and maintain CDM governance, standards, and SOPs to ensure compliance with ICH E6(R3)/ICH E8(R1), 21 CFR Part 11, GDPR (EU), HIPAA (US), and other applicable regulations.
  • Drive innovation in data collection, technology, and analytics (e.g., EDC, eCOA/ePRO, eConsent, data visualization, wearables, eSource, RWE, decentralized clinical trials, risk based quality management, automation, AI-enabled data review).
• Operational Leadership
  • Oversee data management activities for all clinical studies, including database design, data validation, data cleaning, coding, data review, and database lock.
  • Ensure on time, high-quality data delivery to support interim ad hoc and/or final analyses, regulatory submissions, and data monitoring committee (DMC) reviews.
  • Develop and refine metrics, KPIs, quality frameworks, and risk mitigation strategies to optimize CDM execution.
  • Manage the development and maintenance of CRFs/eCRFs, edit checks, and data capture tools.
• Recruit, lead, and mentor a high-performing global CDM team.
• Develop talent through coaching, training, workload planning, and performance management.
• Cultivate a culture of quality, collaboration, accountability, and continuous improvement.
• Select, negotiate with, and oversee CROs, EDC providers, eCOA/ePRO vendors, labs, imaging vendors, and other suppliers that generate clinical data.
• Ensure quality, timeliness, and budget compliance across outsourced activities.
• Act as the primary point of escalation for CDM issues with external partners.
• Cross Functional Collaboration
  • Partner closely with Biostatistics, Clinical Operations, Clinical Science/Medical Monitoring, Safety (PV), Regulatory and Quality to ensure seamless integration of clinical data.
  • Support regulatory interactions, submissions and filings (INDs, NDAs, MAAs), audit readiness, inspection preparation, and responses to health authority queries.
  • Contribute to program strategy, study design, protocol and clinical study report development from a clinical data perspective.
  • Represent CDM in internal and external governance committees, program/study teams, and portfolio planning meetings

• Bachelor’s or Master’s degree in Life Sciences, Data Science, Biostatistics, Public Health, Computer Science, or related field.
• 10+ years of progressive experience in clinical data management within the pharmaceutical, biotech, or CRO industry, with 5+ years of leadership experience managing global CDM teams in early and/or late phase clinical studies.
• Demonstrated success with regulatory submissions (NDA/BLA/MAA) strongly preferred.
• Experience with industry leading EDC systems (e.g., Medidata Rave, Veeva EDC); expertise in RTSM and eCOA/ePRO data integrations that drive efficiency and productivity is highly preferred.
• Demonstrated success managing outsourced data management models.
• Deep understanding of GCP, ICH guidelines, CDISC standards (CDASH, SDTM), and relevant EU and US privacy regulations.
• Strong project management and organizational…