Lead Clinical Data Manager, Consultant

We are seeking an experienced Lead Data Manager, Consultant to oversee all data management deliverables across multiple clinical studies, including activities outsourced to CRO partners.

Remote role but must reside in Massachusetts. Travel to office on occasion is preferred.

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 Associate Director of Data Manager, 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