Biomarker Operations Manager
Share
Job Location:
Seattle, OR - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a highly motivated professional to join Eurofins Biomarker Operations group to work in a dynamic and crossfunctional environment spanning early to latestage clinical development. The Biomarker Operations Manager acts as an important contributor to the clinical development of novel therapies and supports highquality compliant execution of biomarker activities.
This is a hybrid role based in Seattle requiring approximately 2-3 days/week onsite attendance. Onsite presence is as needed / as required and may fluctuate based on business needs study demands and project timelines.
In this position you will coordinate timelines and activities for biomarker projects to ensure highquality and timely delivery of biomarker results and maintain close contact with Biomarker and Imaging program leadership to communicate activities. This role collaborates closely with biomarker leads clinical trial operations medical data management biostatistics and external laboratory vendors and CROs. Core duties include biomarker sample operational logistics clinical trial support and vendor management.
Responsibilities
- Work with colleagues in the Biomarkers Department for the implementation of biomarkers in preclinical validation and clinical studies to meet program goals through a translational understanding of disease states and treatment modalities
- Serve as a key member of clinical study execution teams across multiple disease area programs providing input and guidance on clinical implementation of biomarkers
- Develop biomarker sample handling guidelines for sample processing and manage aspects of biomarker sample collection and informed consent
- Track manage and trigger analyses of biomarker clinical samples through completion including oversight of data transfers according to established timelines
- Resolve biomarker samplerelated questions from investigational sites CROs clinical operations and ethics committees with crossfunctional input (e.g. stability sample usage storage duration)
- Manage work with CROs and external laboratories on biomarker assays (preclinical development validation and clinical trials) including:
- Contract and scope of work management
- Lab manuals and biomarker analysis plans
- Development and maintenance of timelines
- Oversight of deliverables and issue resolution
- Oversee longterm storage inventory tracking and destruction of biomarker samples from clinical and exploratory studies
- Ensure accurate filing of biomarkerrelated documents within the sponsor Trial Master File (TMF)
- Review clinical trial documents for biomarkerrelated content and update as applicable
- Lead and participate in continuous process improvement initiatives including operational efficiencies and data quality enhancements
- Review sections of clinical study protocols biomarker strategy documents and biomarker study reports with appropriate supervision
- Train and advise junior biomarker operations colleagues on best practices systems usage and issue resolution
Qualifications :
- Bachelors degree (BS) in Biology or a related scientific field with 6 or more years of relevant experience or an equivalent combination of education and experience
- Excellent written and verbal communication skills; highly organized detailoriented and able to prioritize effectively in a fastpaced environment
- Strong understanding of scientific principles as applied to biomarker research development and clinical implementation
- Working knowledge of Good Clinical Practices (GCP) and clinical study design and execution
- Demonstrated ability to collaborate effectively with scientists clinical teams vendor laboratories and crossfunctional stakeholders
- Ability to independently oversee biomarker sample logistics and operational activities across multiple studies and programs
- Strong data and computer skills are required including a demonstrated ability to manage complex datasets timelines and operational tracking tools
- Smartsheet experience is strongly preferred and/or demonstrated proficiency with project management platforms data tracking systems and reporting tools used to support clinical operations
- Experience scripting in R is preferred
- Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information :
- Position is full-time Monday- Friday 8:00-5:00 pm.
- May be requested to work on weekends overtime and holidays based on business needs.
- Candidates currently living within a commutable distance of Seattle WA are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
