Director, Clinical Data Management

Work Location: Remote

Summary:

The Director, Clinical Data Management will oversee a diverse portfolio of clinical programs, ensuring the integrity, accuracy, and regulatory compliance of all data management activities from study initiation through closeout.

Responsibilities:

• Lead data management operations for multiple clinical studies, ensuring all activities from database activation to lock are executed efficiently and in compliance with regulatory standards.
• Coordinate and manage relationships with external data management vendors, monitoring their performance, deliverables, and adherence to timelines.
• Oversee the development, validation, and maintenance of clinical databases and ensure data is standardized and audit-ready for regulatory review.
• Review study protocols and related documents to define data capture requirements and ensure case report form (CRF) design aligns with study objectives.
• Participate in comprehensive data review and cleaning activities, including listings, tables, figures, and patient profile assessments for accuracy and consistency.
• Develop and maintain essential data management documentation, such as validation specifications, review guidelines, data management plans, and data transfer requirements.
• Collaborate with cross-functional teams, including biostatistics and programming, to deliver high-quality data outputs and support regulatory submissions.
• Provide leadership, mentorship, and oversight to data management staff, supporting personnel development, training, and continuous process improvement initiatives.

Qualifications:

• Bachelor’s degree required.
• Minimum of 10 years of clinical data management experience within the biotech or pharmaceutical environment.
• Deep expertise with clinical data management methodologies and systems.
• Advanced experience building and managing clinical databases using Medidata Rave.
• Strong understanding of the clinical development lifecycle.
• Highly organized, detail-oriented, and strong written and verbal communicator.
• Able to work independently with urgency in a dynamic, fast-moving environment.
• Demonstrated ability to manage multiple competing priorities and adapt to shifting demands.
• Proven leadership and organizational capabilities, including management of people, timelines, resources, and budgets.
• Willingness to travel up to approximately 20% domestically and internationally.

Published Category: Data Management & Programming