Biomarker Associate

Biomarker Associate

Experienced Biomarker Associate responsible for connecting scientific strategy with operational execution across Phase 1 through Phase 3 clinical trials. The role will manage biomarker operations, logistics, vendors, sample management, clinical documentation, and study related financial activities. The ideal candidate will bring precision medicine biomarker experience combined with clinical trial and project management expertise. This position requires strong cross functional collaboration, excellent organizational skills, and the ability to drive results without formal authority.

Pay Range: $50 to $55 an hour.

Client Industry: Pharmaceutical

Duration: 24 Months Contract (Potential extension based on performance and business needs)

Key Responsibilities:

• Manage biomarker operations and logistics to support clinical trial schedules, resolving or escalating study related issues and risks as appropriate.
• Manage biomarker content within clinical study documents and associated systems, including protocols, informed consent forms, electronic case report forms, and clinical study reports.
• Manage biomarker related regulatory and ethics committee inquiries while maintaining consistent biomarker language and study timelines.
• Develop study related training materials and support training activities for study teams, clinical sites, vendors, and internal colleagues.
• Manage biomarker vendor selection, scope, contract execution, vendor oversight, and compliance with applicable procedures and regulations.
• Manage external vendor agreements and ensure vendors deliver services according to agreed scope, timelines, and requirements.
• Review vendor invoices against agreements and services rendered, approve invoices following verification, and perform monthly financial forecasting.
• Track study enrollment, sample collection, sample shipments, sample inventory, testing status, and receipt of biomarker analysis data from external vendors.
• Coordinate with biomarker leads to verify data and ensure timely transfer of results to appropriate databases.
• Oversee sample analysis, data transfers, storage, shipment, and destruction activities according to study requirements.
• Review laboratory specifications, statements of work, informed consent forms, protocols, and other clinical trial documentation.
• Identify, resolve, and escalate study related risks while collaborating with cross functional teams and external vendors.
• Lead process improvement initiatives and contribute to development and maintenance of biomarker training materials and process guidance.
• Provide mentoring and knowledge sharing to team members while effectively managing multiple priorities in a fast paced environment.
• Apply ICH principles, biorepository procedures, biosample management best practices, ethical guidelines, and Trial Master File requirements.

Required Qualifications:

• Relevant precision medicine biomarker experience in a company or clinical research environment.
• Proven clinical trial and project management experience with a biological science background including biomarkers.
• Experience managing biomarker operations, logistics, sample management, and clinical study activities.
• Experience working with external vendors, vendor agreements, invoices, services, and data deliverables.
• Experience with clinical study documentation including protocols, laboratory specifications, statements of work, informed consent forms, electronic case report forms, and clinical study reports.
• Strong MS Office skills including Excel, Word, and PowerPoint.
• Excellent communication, analytical, organizational, interpersonal, and time management skills with the ability to manage changing priorities.
• Demonstrated ability to run meetings, collaborate cross functionally, and drive activities without formal authority.

Preferred Qualifications:

• Oncology therapeutic area experience.
• Precision medicine biomarker experience in neuroscience or immunology.
• Mentoring or team leadership experience.
• Direct people management experience.
• Project Management certification.
• Experience improving clinical development or biomarker processes.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable.