Senior Director, Clinical Data Management

Job Summary

Required Qualifications

• •Define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs.
• •Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.
• •Develop and monitor KPIs for data quality and operational performance.
• •Manage relationships with Contract Research Organizations (CROs) and other data management vendor partners, ensuring they meet quality and performance standards.
• •Forecast, manage, and provide oversight for departmental budgets, including internal and external expenditures.
• •Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.
• •Experience with global trials and regulatory submissions (FDA, EMA).
• •In-depth understanding of industry standards related to clinical data management (e.g., medical dictionary coding).
• •Guide data management activities for regulatory submissions and represent the department during regulatory inspections and internal audits.
• •Serve as a key liaison and collaborate effectively with cross-functional teams (e.g., Clinical, Quality, Regulatory) and key external stakeholders.
• •Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.
• •Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.
• •Demonstrated ability to lead, motivate, and develop teams.
• •Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.
• •Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.
• •MS, BS/BA degree, or other suitable qualification with relevance to the field.
• •17 or more years' direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.

Desired Qualifications

• •A degree in life science, health informatics, or a related field.
• •Exposure to real-world data (RWD) and decentralized trial models.
• •Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms).