AD, Clinical Data Management

We are seeking an experienced Lead Data Manager to oversee all data management deliverables across multiple clinical studies, including activities outsourced to CRO partners. This role requires a strong technical background, vendor management expertise, and the ability to collaborate effectively across cross-functional teams to ensure high-quality, timely, and compliant data management operations.

Key responsibilities

Oversight & leadership

• Serve as Senior Manager OR Associate Director of Data Management, overseeing all deliverables for activities outsourced to DM CROs across multiple studies
• Manage relationships with CRO vendors and cross-functional partners to ensure high-quality data management activities
• Adhere to data management timelines and budget requirements

Data collection tools & documentation

• Oversee data collection tools including EDC systems, data transfer agreements, and EDC integrations
• Maintain essential data management documents such as DMPs, UAT documents, data edit specifications, annotated case books, and data entry guidelines
• Participate in User Acceptance Testing (UAT) activities for applicable data collection tools

Data quality & cleaning

• Perform quality control reviews for data completeness and accuracy
• Participate in and support data cleaning, query generation and resolution, and medical coding review as needed

Technology & process improvement

• Provide technical expertise to support the adoption and use of data management technologies across the clinical study team
• Contribute to the development of lessons learned, best practices, SOPs, and internal process improvement initiatives
• Support the establishment of systems and tools to ensure clinical data security and integrity

Skills & experience

Required

• 8+ years of experience in clinical data management within the biotechnology or pharmaceutical industry, including CRO oversight
• 5+ years managing vendor relationships and partnerships in a global environment
• Advanced knowledge of data management processes and systems
• Solid understanding of CDISC standards
• Experience using standardized medical terminology including MedDRA and WHODrug
• Excellent interpersonal, communication, and organizational skills; ability to work both independently and within a study team

Preferred

• Experience with data visualization tools