Eikon Therapeutics
Manager, Lab Data Management
Eikon Therapeutics, Jersey City, New Jersey, United States, 07390
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Manager, Lab Data Management
role at
Eikon Therapeutics
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life‑threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in microscopes that enable real‑time, molecular‑resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position The Manager, Lab Data Management will be responsible for timely and high‑quality management of local lab reference ranges supporting the Eikon 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.
This role requires a minimum of three days a week of onsite presence (or more as business needs require) in either our Jersey City, NJ office or our Millbrae, CA office to ensure effective management, operational excellence, and high‑performance delivery of clinical studies and to support expected significant team growth and collaboration.
About You You are a driven individual who focuses on detail, is an expert in data management, and is a strong collaborator.
What You’ll Do
Review and quality control (QC) reference ranges provided by the site or other Eikon functional groups.
Create lab normal range import files and upload them into the EDC local lab module.
Track LNR issues and maintain health status at lab, site, and study level for communication to Data Management leadership or cross‑functional teams.
Manage local lab range units within the EDC system, including change control processes.
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.
Maintain any Data Management owned controlled documents and provide SME knowledge for cross‑functional controlled documents related to LNRs.
Act as the LNR SME for Health Authority inspections and audits.
Serve as the 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 postgraduate degree.
Proven experience in clinical data management from recognized suppliers/vendors, reputable CRO(s) or a Sponsor environment, working on multi‑phase, multi‑therapeutic trials (Oncology preferred) from initiation to completion and associated regulatory submission and inspection preparation.
3+ years focused on collecting and maintaining local lab reference ranges in standard clinical data management systems.
Expertise with lab analytes collected and tested in Oncology clinical trials is preferred.
Ability to work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors.
Sound knowledge of the 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 Microsoft Office skills and familiarity with 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; ability to communicate effectively with senior management and cross‑functional teams.
Good knowledge of CDASH/CDISC (CDASH CRF Library implementation experience preferred).
Knowledge of submission requirements, e.g., NDA/BLA/MAA.
Medical coding experience is a plus.
Benefits
401(k) plan with company matching.
Medical (premiums covered 95%), dental and vision insurance (100% covered).
Mental health and wellness benefits.
Weeklong summer and winter holiday shutdowns.
Generous paid time off and holiday policies.
Life/AD&D insurance (100% covered) and optional supplemental employee‑paid life/AD&D policies.
Enhanced parental leave benefit.
Daily subsidized lunch program when on‑site.
The expected salary range for this role is $104,000 to $114,000 depending on skills, competency, and market demand.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third‑party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third‑party agency or firm associated with unsolicited resumes.
#J-18808-Ljbffr
Manager, Lab Data Management
role at
Eikon Therapeutics
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life‑threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in microscopes that enable real‑time, molecular‑resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position The Manager, Lab Data Management will be responsible for timely and high‑quality management of local lab reference ranges supporting the Eikon 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.
This role requires a minimum of three days a week of onsite presence (or more as business needs require) in either our Jersey City, NJ office or our Millbrae, CA office to ensure effective management, operational excellence, and high‑performance delivery of clinical studies and to support expected significant team growth and collaboration.
About You You are a driven individual who focuses on detail, is an expert in data management, and is a strong collaborator.
What You’ll Do
Review and quality control (QC) reference ranges provided by the site or other Eikon functional groups.
Create lab normal range import files and upload them into the EDC local lab module.
Track LNR issues and maintain health status at lab, site, and study level for communication to Data Management leadership or cross‑functional teams.
Manage local lab range units within the EDC system, including change control processes.
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.
Maintain any Data Management owned controlled documents and provide SME knowledge for cross‑functional controlled documents related to LNRs.
Act as the LNR SME for Health Authority inspections and audits.
Serve as the 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 postgraduate degree.
Proven experience in clinical data management from recognized suppliers/vendors, reputable CRO(s) or a Sponsor environment, working on multi‑phase, multi‑therapeutic trials (Oncology preferred) from initiation to completion and associated regulatory submission and inspection preparation.
3+ years focused on collecting and maintaining local lab reference ranges in standard clinical data management systems.
Expertise with lab analytes collected and tested in Oncology clinical trials is preferred.
Ability to work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors.
Sound knowledge of the 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 Microsoft Office skills and familiarity with 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; ability to communicate effectively with senior management and cross‑functional teams.
Good knowledge of CDASH/CDISC (CDASH CRF Library implementation experience preferred).
Knowledge of submission requirements, e.g., NDA/BLA/MAA.
Medical coding experience is a plus.
Benefits
401(k) plan with company matching.
Medical (premiums covered 95%), dental and vision insurance (100% covered).
Mental health and wellness benefits.
Weeklong summer and winter holiday shutdowns.
Generous paid time off and holiday policies.
Life/AD&D insurance (100% covered) and optional supplemental employee‑paid life/AD&D policies.
Enhanced parental leave benefit.
Daily subsidized lunch program when on‑site.
The expected salary range for this role is $104,000 to $114,000 depending on skills, competency, and market demand.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third‑party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third‑party agency or firm associated with unsolicited resumes.
#J-18808-Ljbffr