Clinical Biomarker & Diagnostics (CBD) Operations Lead

AllSTEM Connections; United States; Remote; USD 198,000 - 210,000; Full time

Job summary

AllSTEM Connections seeks a Clinical Biomarker & Diagnostics Operations Lead to manage operational tasks for biomarker strategies in General Medicine. This role is a 12-month contract focused on project management, requiring strong leadership and communication skills among other qualifications. The position offers remote flexibility within various U.S. time zones.

Benefits

Medical insurance

Vision insurance

Qualifications

• Minimum 2 years in Biomarker Operations.
• Experience managing teams or projects.
• Familiarity with ICH guidelines and ethical compliance.

Responsibilities

• Manage operational activities for biomarker strategies.
• Oversee biosample collection and analysis logistics.
• Ensure compliance with internal SOPs and GCP guidelines.

Skills

Project management

Resource allocation

Critical reasoning

Effective communication

Education

Degree in Life Sciences

Project Management Certification

Job description

Clinical Biomarker & Diagnostics (CBD) Operations Lead

Clinical Biomarker & Diagnostics (CBD) Operations Lead

Direct message the job poster from AllSTEM Connections

AllSTEM Connections is seeking a Clinical Biomarker & Diagnostics (CBD) Operations Lead to work remotely in PST/MST/CST/EST time zones.

This is a 12-month contract position. Possible extension/temp-to-hire.

Hourly rate is up to $95/hour.

M-F, 8AM - 5PM.

SUMMARY:

The Clinical Biomarker & Diagnostics (CBD) Operations Lead is responsible for managing operational activities to execute The Company’s biomarker and diagnostic strategies within General Medicine therapeutic areas, including Rare Disease, Inflammation, and Cardio Metabolic. This is a project management-focused role (not a clinical trial manager or researcher position) and serves as the primary point of contact for biomarker operational planning and delivery across clinical programs.

RESPONSIBILITIES:

• Lead the implementation of biomarker and diagnostic operational plans across clinical programs and studies
• Oversee biosample collection, processing, storage, and analysis logistics to ensure feasibility and cost-effectiveness
• Manage project timelines, contracts, budgets, and forecasting for biomarker activities
• Coordinate assay development and execution with central/reference laboratories
• Ensure consistent and high-quality data collection, reconciliation, and reporting
• Review and contribute to protocol development, informed consent forms (ICFs), lab manuals, and database setup
• Participate in site initiation visits and train clinical sites on sample collection procedures
• Track sample collection and reconcile data across clinical studies
• Organize and facilitate biomarker sub-team meetings, dashboards, and deliverable tracking
• Serve as primary operational contact for internal and external stakeholders including Clinical Ops, BioSample Management, Biomarker Leads, and CROs
• Ensure compliance with ICH-GCP and internal SOPs
• Operational plans for biosample collection and assay execution
• Sample tracking reports and reconciliation plans
• Dashboards and timelines for biomarker activities
• Meeting agendas, minutes, and action trackers
• Written project communication artifacts (candidates will be asked to provide neutral, non-confidential examples during screening)

QUALIFICATIONS:

• Candidates with prior experience as:

Biomarker Operations Manager

Biosample Operations Manager

Biospecimen Operations Manager

• Experience directly managing people or leading teams, projects, or programs
• Demonstrated ability to allocate resources and manage complex initiatives
• Minimum 2 years in Biomarker Operations
• In-depth knowledge of biospecimen types and lifecycle management
• Clinical development experience, including protocol and ICF contributions
• Strong project management skills with knowledge of tools and techniques
• Demonstrated written communication capabilities (e.g., emails, meeting notes, timelines)
• Critical reasoning and complex problem-solving skills
• Ability to manage competing priorities independently
• Excellent time management, planning, and organizational skills
• Effective verbal and written communication
• Degree in Life Sciences (advanced degree such as MSc preferred)
• Project Management certification
• Familiarity with ICH guidelines, global regulatory standards, and ethics/compliance requirements
• Experience supporting biomarker strategies in General Medicine therapeutic areas

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Project Management, Research, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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