Clinical Lab Data Manager (Lab Normal Ranges) –
*****This role is a MUST BE ONSITE/HYBRID 3 days per week in Hudson County NJ*****
*****MUST HAVE Experience loading of Lab Normal Ranges (LNR) within EDC system****
*****Relocation is NOT available for this role***
*****Sponsorship or transfer of a Visa is NOT available for this role***
Summary:
Expanding biopharmaceutical company is looking to hire a Clinical Lab Data Manager within their Data Management team. This role is responsible for management of local lab reference ranges, supporting their portfolio which includes loading of Lab Normal Ranges (LNR) within the EDC system and management of LNR issue tracking and health status of a particular lab, site or study. This includes being an expert in data management and a strong collaborator.
Responsibilities:
- In this role, you will 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.
- Will manage local lab range units within the EDC system including change control process.
- Review for quality control, reference ranges provided by the site or other functional groups.
- Create lab normal range import file and uploads it into EDC local lab module.
- Collaborate with Data Management team and other groups, and study site personnel to continuously improve the collection and loading of LNR data.
- Provide LNR training for Data Management and other groups/ functions as required.
- 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 primary point of contact for internal and external study team members regarding local lab reference ranges.
- At times, serve as a backup for medical coding activities.
Required:
- Minimum five years of Pharma/Biotech or CRO experience with a Bachelor's degree in related field.
- Strong Data Manager experience within clinical data management gained from working on multi-phase, multi-therapeutic area and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
- Oncology experience preferred but not a must.
- Minimum three plus years of experience focused on the collection and maintenance of local lab reference ranges within standard clinical data management systems.
- Expert with Lab analytes collected and tested in Oncology clinical trials is preferred.
- Able to work on several 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, 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.
- Knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
- Knowledge of submission requirements, (NDA)/ (BLA)/ (MAA).
- Must have LNR (Lab Normal Ranges) experience
- Medical Coding experience is a plus.
Base salary up to $115,000 plus bonus and other benefits.
**No sponsorship available for this role at this time***