Director, Clinical Data Management
Accountabilities: The Director, Clinical Data Management will provide strategic and operational leadership for clinical data management activities across global Phase 2/3 programs. The role requires strong expertise in outsourced clinical development models, vendor oversight, regulatory compliance, and cross-functional collaboration to ensure timely and high-quality clinical data delivery.
Lead sponsor-side clinical data management activities for Phase 2/3 clinical trials, particularly within rare disease and neonatology programs.
Develop and execute data management strategies aligned with clinical development goals, regulatory requirements, and submission timelines.
Serve as the primary data management point of contact for internal stakeholders and external partners.
Oversee CROs, electronic data capture providers, central laboratories, imaging vendors, and other specialized service providers.
Manage vendor performance across scope, budget, timelines, quality metrics, and operational deliverables.
Review and approve key data management documents, including Data Management Plans, validation plans, edit check specifications, transfer agreements, database design specifications, and UAT documentation.
Oversee database build, testing, deployment, maintenance, and database lock activities.
Ensure data review, query management, coding, reconciliation, and cleaning activities meet quality and timeline expectations.
Coordinate external data integrations, including laboratory, safety, pharmacokinetic, and device-related data.
Lead cross-functional data review meetings and drive resolution of data issues and discrepancies.
Support interim analyses, Data Monitoring Committee activities, and final database lock processes.
Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements.
Maintain inspection readiness for clinical data management processes and support regulatory submissions.
Contribute to SOP development, process improvements, and quality system enhancements.
Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Regulatory Affairs, Pharmacovigilance, and Quality teams.
Provide data management expertise during protocol development, study startup, and operational planning.
Mentor teams and influence stakeholders within a matrixed, outsourced environment.
Requirements:
The ideal candidate is an experienced clinical data management leader with a strong background in global clinical trials, regulatory submissions, and outsourced development models. You should have the ability to manage complex programs independently while collaborating effectively with multidisciplinary teams.
Bachelor’s degree in Life Sciences, Biostatistics, Computer Science, Nursing, Public Health, or a related field; advanced degree preferred.
12–15+ years of clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
Strong preference for biotechnology experience and sponsor-side clinical data management leadership.
Demonstrated experience leading global Phase 2/3 clinical trials.
Experience managing inspection readiness activities and supporting regulatory inspections.
Significant experience overseeing CROs and external vendors within a fully outsourced operating model.
Experience supporting regulatory submissions such as NDA, BLA, or MAA packages.
Prior experience working with rare disease, pediatric, or neonatal clinical studies is highly desirable.
Strong knowledge of EDC platforms including Medidata Rave, Oracle InForm, and Veeva Vault CDMS.
Experience with CDISC standards, including SDTM and controlled terminology.
Familiarity with eCOA platforms, laboratory data transfers, safety reconciliation, and data review tools.
Understanding of risk-based quality management principles.
Excellent leadership, vendor management, and project management skills.
Ability to influence cross-functional stakeholders without direct authority.
Exceptional written and verbal communication skills.
Strategic mindset combined with strong attention to detail.
Ability to succeed in a fast-paced, resource-conscious environment.
Strong commitment to improving patient outcomes through high-quality clinical research.
Benefits:
Fully remote full-time opportunity based in India.
Competitive annual salary package.
Opportunity to work on global clinical development programs with meaningful patient impact.
Exposure to innovative rare disease and specialty healthcare research.
Collaboration with international clinical, scientific, and operational teams.
Leadership role with significant ownership and strategic influence.
Opportunity to work with advanced clinical data platforms and regulatory processes.
Professional growth within a dynamic and collaborative environment.
Flexible remote work structure aligned with global collaboration.
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