Immunovant · 7 hours ago

Senior Director, Data Management

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$250K/yr - $268K/yr

15+ years exp

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BiotechnologyPharmaceutical

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Responsibilities

Serves as a key member of the Data Management Leadership Team, contributing to the establishment of an effective, well-functioning organization.

Oversees management of all clinical trial data across multiple programs and indications.

Interface with CROs to ensure that all clinical trial data are collected, managed, and reported clearly, accurately, and securely based on study protocol and requirements, including eCRF designs to study database locks.

Responsible for the implementation of clinical study database, startup documents, reports, and external data/system planning and incorporation/integration.

Ensure that databases are validated and ready for transfer and analysis.

Ensure that any subcontracted DM activities are delivered in line with the project expectations (timelines, quality and budget).

Track data management performance across projects and share project tracking with the cross-functional development team and Head of Data Management.

Provide line management of internal Data Management team members including recruitment, talent development and performance appraisal and/or manage the functional activities of internal Data Management team members allocated to projects.

Support the development and implementation of Data Management SOPs, work instructions, etc. and ensure compliance within line management team.

Support the selection and implementation of new Data Management Innovations such as Data Review tools.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical data managementClinical databasesData management systemsElectronic data capture (EDC)Biologics experienceImmunotherapy experienceGCP guidelinesICH guidelinesAdvanced degreeProject management skillsCollaboration skills

Required

15+ years of Clinical data management experience in biotech and/or pharmaceutical industry

Strong understanding of laws and policies governing the pharmaceutical industry as they relate to data management, including CRF, GCP, and ICH guidelines

Mastery of clinical databases, data management systems, and electronic data capture (EDC)

Excellent analytical, organizational, and project management skills, with strong attention to detail

Consistently able to produce quick, thorough, and accurate work

Entrepreneurial spirit, willing to go above and beyond to manage multiple projects simultaneously and achieve key objectives in a fast-paced and fluid startup environment

Natural collaborator who enjoys working on a cross-functional team