Lab Data Manager

Lab Data Manager

Hybrid - Jersey City, NJ or San Francisco, CA

Position

The Lab Data Manager will be responsible for timely and high-quality management of local lab reference ranges supporting the client's portfolio including the loading of Lab Normal Ranges (LNR) within the EDC system and the management of LNR issue tracking and health status of a particular lab, site or study.

Responsibilities

• Review and quality control (QC) the reference ranges provided by the site or, if applicable, other functional groups.
• Create lab normal range import file and uploads it into EDC local lab module.
• Be responsible for LNR issue tracking and maintaining health status at lab, site, and study level for communication to Data Management leadership or other cross functional teams.
• Manage local lab range units within the EDC system including change control process.
• Collaborate with Data Management colleagues, and study site personnel to continuously improve the collection and loading of LNR data.
• Provide LNR training for Data Management and other functions as required.
• Be responsible for the creation and maintenance of any Data Management owned controlled documents and provide SME knowledge to any cross functional controlled documents related to LNRs.
• Act as the LNR SME for Health Authority inspections and audits.
• Serve as a primary point of contact for internal and external study team members regarding local lab reference ranges.
• Serve as a backup for medical coding activities.

Qualifications

• 6+ years of experience with a Bachelor's degree in a health related field (Chemistry, Nursing, etc.); or 4+ years of experience with a post graduate degree
• Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic (Oncology experience will be preferred) and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
• 3+ years of experience focused on the collection and maintenance of local lab reference ranges within standard clinical data management systems.
• Expertise with Lab analytes collected and tested in Oncology clinical trials is preferred.
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
• Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management and local lab ranges.
• Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
• Experience using a Local Lab Module within a standard EDC system is required.
• Strong project management, metrics analysis and reporting methodologies experience.
• Excellent oral and written communication skills and able to communicate effectively with senior management and cross-functional teams.
• Good knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
• Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].