Eikon Therapeutics · 2 weeks ago
Manager, Lab Data Management
Millbrae, CA
Full-time
Onsite
Mid, Senior Level
$104K/yr - $114K/yr
6+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. The Manager, Lab Data Management will oversee the management of local lab reference ranges, ensuring high-quality data management and collaboration across teams to support clinical studies.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Review and quality control (QC) the reference ranges provided by the site or, if applicable, other Eikon 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, other Eikon functions, and study site personnel to continuously improve the collection and loading of LNR data
Provide LNR training for Data Management and other Eikon 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
Qualification
Required
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 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
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; 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
Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
Preferred
Oncology experience will be preferred
Expertise with Lab analytes collected and tested in Oncology clinical trials is preferred
Veeva CDMS preferred
CDASH CRF Library implementation experience is preferred
Medical Coding experience is a plus
Benefits
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
2026-01-12
Renaissance Capital
2026-01-11
Renaissance Capital
2026-01-11
Company data provided by crunchbase