Job Description

ROLE OVERVIEW

The Lead Clinical Data Manager will provide strategic and operational leadership for clinical data management activities across Phase 2/3 clinical programs in rare disease and neonatology. Operating within a fully outsourced model, this individual will serve as the sponsor subject matter expert responsible for overseeing external vendors, ensuring data quality and integrity, and supporting regulatory submissions.

The successful candidate will partner closely with Clinical Operations, Biostatistics, Medical, Regulatory Affairs, Pharmacovigilance, and external CROs to ensure timely delivery of high-quality clinical data in support of global development programs. Experience managing complex studies in vulnerable populations, including pediatric patients, is highly desirable.

For a small biotech, this role requires an individual who is comfortable being very hands-on despite the "lead" title: the individual will serve as strategist, vendor manager, escalation point, and operational reviewer simultaneously, rather than managing a large internal data management team.

KEY RESPONSIBILITIES

Clinical Data Management Leadership

• Lead all sponsor-side data management activities for Phase 2/3 clinical trials in rare disease and neonatology.
• Develop and execute data management strategies aligned with clinical development, regulatory, and submission timelines.
• Act as the primary point of contact for all data management deliverables across internal teams and external partners.
• Provide oversight of data management activities conducted by CROs and other vendors within a fully outsourced operating model.

Vendor and CRO Oversight

• Manage relationships with CROs, electronic data capture ( EDC ) providers, central laboratories, imaging vendors, and other specialty vendors.
• Review and approve key data management documents, including:
  • Data Management Plans ( DMPs )
  • Data Validation Plans
  • Edit Check Specifications
  • Data Transfer Agreements
  • Database Design Specifications
  • User Acceptance Testing ( UAT ) documentation
• Monitor vendor performance against scope, budget, quality metrics, and timelines.
• Lead data governance meetings and escalate risks and issues as appropriate.

Study Execution

• Oversee database build, testing, deployment, maintenance, and database lock activities.
• Ensure data review, query management, coding, reconciliation, and cleaning activities are performed in accordance with study timelines and GCP .
• Oversee the coordination of external data integrations, including laboratory, safety, pharmacokinetic, and device data.
• Lead internal cross-functional data review meetings and drive resolution of data discrepancies.
• Support interim analyses, Data Monitoring Committee activities, and final database lock.

Regulatory and Quality Compliance

• Ensure compliance with ICH-GCP , FDA , EMA , and applicable global regulatory requirements.
• Maintain inspection readiness for clinical data management processes and deliverables.
• Support preparation of regulatory submissions, including NDA/BLA/MAA packages.
• Contribute to development and continuous improvement of SOPs, work instructions, and quality systems.

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
• Provide data management expertise during protocol development and study start-up activities.
• Assess protocol feasibility and identify operational risks related to data collection in neonatal and rare disease populations.
• Present study status, risks, and mitigation plans to senior leadership and governance committees.

Qualifications

Required Education and Experience

• Bachelor's degree in Life Sciences, Biostatistics, Computer Science, Nursing, Public Health, or a related discipline; advanced degree preferred.
• Minimum 12-15 years of clinical data management experience within the biotechnology, pharmaceutical, or CRO industry. Strong preference for biotechnology experience.
• Demonstrated experience leading global Phase 2/3 clinical trials .
• Demonstrated experience leading DM activities for Inspection Readiness.
• Significant sponsor-side experience operating within a fully outsourced clinical development model.
• Experience supporting regulatory submissions ( NDA, BLA, MAA ).
• Prior experience with rare disease and/or pediatric or neonatal clinical studies.

Technical Expertise

• Strong knowledge of EDC platforms such as:
  • Medidata Rave
  • Oracle InForm
  • Veeva Vault CDMS
• Experience with CDISC standards , including SDTM and controlled terminology.
• Familiarity with electronic clinical outcome assessments ( eCOA ), laboratory data transfers, and safety reconciliation.
• Understanding of data visualization and review tools.
• Knowledge of risk-based quality management principles.

Competencies

• Strong leadership and vendor-management skills within a matrixed, outsourced environment.
• Excellent project management and organizational abilities.
• Ability to influence cross-functional stakeholders without direct authority.
• Exceptional written and verbal communication skills.
• Strategic mindset with strong attention to detail.
• Ability to thrive in a fast-paced, resource-constrained biotech environment.

Commitment to improving outcomes for patients with rare diseases and neonatal conditions.

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