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Biomarker Operation Manager Jobs in Indiana (NOW HIRING)

Pfizer

Build translational biomarker frameworks that link preclinical insights to early clinical decisions ... Experience managing large-scale scientific, clinical and operational data * Familiarity with data ...

Indiana University

Research Analyst

Indianapolis, IN · On-site

$50K - $60K/yr

... manages intake into the biomarker lab. * Assists with data management, quality control (QC), and ... Provides guidance and support to junior-level staff in laboratory operations. * May develop ...

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Biomarker Operation Manager information

What does a biomarker operation manager do?

A Biomarker Operation Manager oversees the planning, execution, and management of biomarker studies within clinical trials. They coordinate with cross-functional teams to ensure the proper selection, collection, analysis, and reporting of biomarker data. Their role is crucial in ensuring compliance with regulatory requirements, timelines, and scientific objectives. Biomarker Operation Managers also work closely with external vendors and laboratories to ensure high-quality and timely data delivery, supporting the overall drug development process.

What are the key skills and qualifications needed to thrive as a biomarker operation manager?

To excel as a Biomarker Operation Manager, you need a solid background in biomedical sciences or a related field, experience in clinical trials, and a deep understanding of biomarker development and validation. Familiarity with laboratory information management systems (LIMS), regulatory compliance tools, and project management software is typically required. Exceptional organizational, communication, and leadership skills are crucial for coordinating cross-functional teams and managing complex projects. These competencies ensure the timely, compliant, and efficient delivery of biomarker strategies that are critical to successful clinical research and drug development.

What are some common challenges faced by a biomarker operation manager when coordinating multi-site clinical trials?

A Biomarker Operation Manager often encounters challenges such as ensuring consistent sample collection and processing across multiple sites, maintaining strict compliance with regulatory standards, and facilitating effective communication between cross-functional teams. Managing logistics for timely shipment and storage of biological specimens, as well as addressing unforeseen protocol deviations, are also key difficulties. Successfully navigating these challenges requires strong organizational skills, attention to detail, and proactive problem-solving to support seamless trial execution.

What is the difference between Biomarker Operation Manager vs Biomarker Scientist?

AspectBiomarker Operation ManagerBiomarker Scientist
Primary RoleOversees biomarker assay operations, manages teams, ensures quality controlConducts biomarker research, develops assays, analyzes data
Required CredentialsBachelor's or Master's in life sciences, project management experienceAdvanced degree (PhD or Master's), laboratory expertise
Work EnvironmentClinical labs, research organizations, biotech companiesResearch labs, academic institutions, pharmaceutical companies
Industry UsageCommon in clinical trial settings and biotech firmsPrimarily in research and development roles

The Biomarker Operation Manager focuses on managing biomarker assay operations and team coordination, ensuring quality and compliance. In contrast, the Biomarker Scientist is dedicated to conducting research, developing new assays, and analyzing data. Both roles require scientific credentials, but their daily responsibilities and work environments differ significantly.

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What job categories do people searching Biomarker Operation Manager jobs in Indiana look for?

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Biomarker Operation Manager jobs near you

ELN Administrator - Bioanalytical Support

Kelly Services

Franklin, IN

$60K - $70K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 5 days ago

Job description

ELN Administrator - Bioanalytical Support
Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting opportunity as an ELN Administrator (Bioanalytical Support) with a biotechnology and life science leader.
Location: Onsite in Franklin, IN
Duration: Direct Hire
Schedule: Mon-Fri, 1st shift
Compensation: $60,000-70,000/yr
SUMMARY
The ELN Administrator is responsible for the management, creation, maintenance, and continuous improvement of Electronic Lab Notebook (ELN) templates used at the company workflows within a regulated Contract Research Organization (CRO). This role supports scientific and operational teams by translating study protocols, assay methods, and regulatory requirements into standardized, compliant, and user-friendly electronic templates to support our Logistics, Metrology, Chemical Reagent Team, and Bioanalytical groups. 
The ELN Administrator serves as the Technical Lead and SME (Subject Matter expert) for the Sapio ELN platform.
The position plays a critical role in ensuring data integrity, consistency, and efficiency in bioanalytical study execution, while maintaining compliance with GLP, GCP, and 21 CFR Part 11 requirements. 
RESPONSIBILITIES
ELN Template Development & Maintenance 
  • Design, build, and maintain ELN templates for ligand binding assays, including PK, immunogenicity (ADA), and biomarker workflows. 
  • Design, build, and maintain ELN templates for Critical Reagent workflows. 
  • May require user to translate study protocols, assay methods, and SOPs into structured, standardized ELN formats. 
  • Ensure templates support accurate, complete, and consistent data capture. 
  • Maintain version control and lifecycle management of ELN templates. 
  • Serves as a Subject Matter Expert (SME) for ELN Template generation, qualification and implementation within a regulatory environment.  
  • Other duties as assigned.  
Regulatory Compliance & Data Integrity 
  • Ensure all ELN templates comply with GLP, GCP, and 21 CFR Part 11 requirements for electronic records and signatures. Other regulations may apply.  
  • Partner with Quality Assurance (QA) to ensure templates meet audit and inspection readiness standards. 
  • Incorporate data integrity principles (ALCOA+) into all template designs. 
  • Support audit preparation and responses related to ELN processes. 
Cross-Functional Collaboration 
  • Work closely with various team members to understand workflow requirements. 
  • Collaborate with IT and ELN system administrators (internally & externally) to implement template functionality and updates. 
Process Improvement & Standardization 
  • Identify opportunities to improve template usability, automation, and efficiency. 
  • Drive standardization across assays, studies, and clients where appropriate. 
  • Contribute to SOP development and best practices for ELN usage. 
User Support & Training 
  • Provide guidance and support to laboratory staff on ELN template usage, training and deployment.  
  • Assist in troubleshooting template-related issues. 
  • Develop training materials and conduct user training sessions as needed. 
Documentation & Change Management 
  • Manage template change requests and document all updates in accordance with change control procedures. 
  • Maintain clear documentation of template specifications and configurations. 
  • Other duties as assigned. 

QUALIFICATIONS
Education 
  • Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field or equivalent combination of scientific and administrative experience. 
Experience 
  • 2–5+ years of experience in a regulated laboratory, CRO, or pharmaceutical environment. 
  • Experience working with Electronic Lab Notebooks (e.g., IDBS E-Workbook, Benchling, LabWare ELN, or similar. Sapio Is preferred). 
  • Experience in developing Electronic Lab Notebook templates is preferred. 
  • Familiarity with bioanalytical workflows, preferably ligand binding assays. 
Technical Skills 
  • Strong attention to detail with the ability to translate scientific procedures into structured digital templates. 
  • Proficiency in data structuring, formatting, and workflow logic. 
  • Experience with document control and versioning systems. 
  • Basic understanding of assay workflows (ELISA, MSD, etc.) is highly desirable. 
Regulatory Knowledge 
  • Understanding of GLP, GCP, and 21 CFR Part 11 requirements. 
  • Familiarity with data integrity principles (ALCOA+). 
Preferred Qualifications 
  • Experience specifically supporting ligand binding assay (LBA) environments (PK, ADA, biomarkers). 
  • Experience using an Electronic Laboratory Notebook system, generation and versioning of templates and Exposure to LIMS and other laboratory informatics systems. 
  • Experience with validation of computerized systems (CSV) or template validation. 
  • Prior experience in template automation or workflow optimization. 
  • P#1

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States. 
Send resumes to: Jacqueline.Sayoc@KellyScientific.com
 
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.