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

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

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