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 responsibilitiesOversight & leadershipServe as Associate Director of Data Manager, overseeing all deliverables for activities outsourced to DM CROs across multiple studiesManage relationships with CRO vendors and cross-functional partners to ensure high-quality data management activitiesAdhere to data management timelines and budget requirementsData collection tools & documentationOversee data collection tools including EDC systems, data transfer agreements, and EDC integrationsMaintain essential data management documents such as DMPs, UAT documents, data edit specifications, annotated case books, and data entry guidelinesParticipate in User Acceptance Testing (UAT) activities for applicable data collection toolsData quality & cleaningPerform quality control reviews for data completeness and accuracyParticipate in and support data cleaning, query generation and resolution, and medical coding review as neededTechnology & process improvementProvide technical expertise to support the adoption and use of data management technologies across the clinical study teamContribute to the development of lessons learned, best practices, SOPs, and internal process improvement initiativesSupport the establishment of systems and tools to ensure clinical data security and integritySkills & experienceRequired8+ years of experience in clinical data management within the biotechnology or pharmaceutical industry, including CRO oversight5+ years managing vendor relationships and partnerships in a global environmentAdvanced knowledge of data management processes and systemsSolid understanding of CDISC standardsExperience using standardized medical terminology including MedDRA and WHODrugExcellent interpersonal, communication, and organizational skills; ability to work both independently and within a study teamPreferredExperience with data visualization tools

Created: 2026-05-09