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Biomarker Operation Manager Jobs (NOW HIRING)

The Biomarker Operations Manager is responsible for the operational planning and logistics required to execute biomarker activities for clinical projects. This role does not own biomarker strategy or ...

The Biomarker Operations Manager is responsible for the operational planning and logistics required to execute biomarker activities for clinical projects. This role does not own biomarker strategy or ...

The Biomarker Operations Manager is responsible for the operational planning and logistics required to execute biomarker activities for clinical projects. This role does not own biomarker strategy or ...

The Biomarker Operations Manager is responsible for the operational planning and logistics required to execute biomarker activities for clinical projects. This role does not own biomarker strategy or ...

The Biomarker Operations Manager is responsible for the operational planning and logistics required to execute biomarker activities for clinical projects. This role does not own biomarker strategy or ...

This individual will closely work with the biomarker operations and research team to ensure timely ... Manage multiple specialty vendor labs and maintain strong oversight on deliverables (proposals ...

Clinical Biomarker Lead

San Diego, CA ยท On-site

$150K - $163K/yr

This individual will closely work with the biomarker operations and research team to ensure timely ... Manage multiple specialty vendor labs and maintain strong oversight on deliverables (proposals ...

Clinical Biomarker Lead

San Diego, CA ยท On-site

$150K - $163K/yr

This individual will closely work with the biomarker operations and research team to ensure timely ... Manage multiple specialty vendor labs and maintain strong oversight on deliverables (proposals ...

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Biomarker Operation Manager information

What are the key skills and qualifications needed to thrive as a Biomarker Operation Manager, and why are they important?

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 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.

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 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.
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What job categories do people searching Biomarker Operation Manager jobs look for? The top searched job categories for Biomarker Operation Manager jobs are:
Manager, Biomarker Operations

Manager, Biomarker Operations

Artiva Biotherapeutics, Inc.

San Diego, CA โ€ข On-site

$130K - $142K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 21 days ago


Job description

About Artiva:
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNKยฎ, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com.
Job Summary:
Reporting to the Senior Manager, Biomarker Operations, the Manager, Biomarker Operations is responsible for managing operational aspects of the clinical biomarker projects. This position will be responsible for managing the biomarker operation of Artiva's clinical studies by coordinating sample-related operations with Clinical Operations, contract executions, and communication between the Translational Science group with external contract research organizations (CRO) and internal lab personnel. The successful candidate will have strong communication and project management skills. Understanding and experience with drug development and clinical trial process is a prerequisite for this position.
Duties/Responsibilities:
  • Oversee day-to-day biomarker operations of Artiva's clinical trials including but not limited to execution of biomarker operations with external vendors, ensuring CROs meet all key deliverables and timelines
  • Working closely with the translational leads, manages documentation and performance of biomarker assays conducted at CROs, ensures timely delivery of high-quality biomarker data, and supports CRO audits
  • Ensures timely collection kit preparation and sample testing database builds including review of required documentation
  • Works with Clinical Operations and CRO to prepare for site activations including preparation of training materials
  • Manages collection kit logistics, sample inventory, and sample testing at CROs; tracks and follows up on discrepancies and missing information
  • Coordinates shipping and testing scheduling with central lab or 3rd party vendors
  • Contributes to data transfer specifications review and implementation
  • Assist the internal biomarker laboratory with sample shipping and receiving
  • Contributes to translational logistics meetings

Requirements:
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, and efficient. Excellent communication, project management and interpersonal skills. Able to develop important relationships with key internal stakeholders and external entities.
  • Bachelor's or Master's degree in biology, immunology, or related fields and/or project management experience is required with a minimum of 6 - 8 years' experience within the biotechnology or pharmaceutical industry
  • Demonstrated experience of managing biomarker sample operation of clinical trials, working with CROs to execute biomarker study plan.
  • Excellent communication skills, verbal and written
  • Understanding and experience with drug development and clinical trial process

Competencies
  • Time Management
  • Risk Management
  • Operations Management
  • Finance
  • Business Planning
  • Implementing Plans
  • Analysis and Reporting
  • Negotiation

Attributes
  • Honesty/Integrity
  • Communication skills
  • Self-starter
  • Forward thinking
  • Creative/imaginative
  • Confident
  • Self-controlled
  • Intuitive
  • Positive
  • Committed
  • Ambitious/driven
  • Agile
  • Collaborative
  • Transparent

In addition to a great culture, we offer:
  • A beautiful facility
  • An entrepreneurial, highly collaborative, and innovative environment
  • Comprehensive benefits, including:
  • Medical, Dental, and Vision
  • Group Life Insurance
  • Long Term Disability (LTD)
  • 401(k) Retirement Plan
  • Employee Assistance Program (EAP)
  • Flexible Spending Account (FSA)
  • Paid Time Off (PTO)
  • Company paid holidays, including the year-end holiday week
  • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

If all this speaks to you, come join us on our journey!
Base Salary: $130,000 - $142,000. Exact compensation may vary based on skills and experience.