Biomarker Operations Specialist

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Overview of the Role

As a Biomarker Operations Specialist at ICON, you will become part of the world's largest and most comprehensive clinical research organization. This company is powered by healthcare intelligence and aims to innovate in the life sciences through extensive research and effective implementation of biomarker strategies.

Responsibilities

You will be responsible for numerous crucial tasks, including:

• Collaborating within the Biomarkers Department to implement biomarkers in both pre-clinical validation and clinical studies, ensuring that program goals are met through a translational understanding of diseases and treatment modalities.

• Serving as a key member of clinical study execution teams, guiding the clinical implementation of biomarkers.

• Developing guidelines for biomarker sample handling that encompass processes for sample collection and consent management.

• Tracking and overseeing the analysis of biomarker clinical samples to ensure completion and timely data transfers.

• Resolving queries related to biomarker sample handling from various stakeholders including sites, CROs (Clinical Research Organizations), and ethical committees, ensuring thorough collaboration among functional teams.

• Managing collaborations with CROs on biomarker assays, which includes overseeing contract management, writing scope of work documents, lab manuals, and biomarker analysis plans, in addition to managing timelines and deliverables.

• Taking responsibility for the long-term storage and destruction of biomarker samples that stem from clinical or exploratory studies.

• Filing necessary documentation in the clinical trial sponsor’s Trial Master File (TMF).

• Reviewing clinical trial documents, such as the study dossier and various logs, and making updates as necessary.

• Assisting with oversight of budgets related to assigned biomarker projects.

• Participating in process improvement projects aimed at enhancing Standard Operating Procedures (SOPs), work instructions, and training materials designed for biomarker management.

• Reviewing sections of clinical study protocols, biomarker strategy documents, and reports under supervision.

Qualifications Required

To qualify for the Biomarker Operations Specialist position, you should possess:

• A Bachelor’s degree in Biology or a related field, along with at least four years of relevant experience or an equivalent combination of education and experience.

• Excellent skills in written and oral communication, while being organized and detail-oriented. You should also demonstrate capability in prioritizing tasks and planning effectively.

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• A solid understanding of general scientific principles applied to biomarker research, development, and implementation.

• Familiarity with Good Clinical Practices (GCP), clinical study designs, and implementations is a requirement.

Benefits and Company Culture

ICON places a high premium on the quality of its personnel and has cultivated a diverse, rewarding culture:

• Competitive salary alongside a broad range of benefits structured to maintain work-life balance.

• Various annual leave entitlements and flexible health insurance options tailored to meet the diverse needs of your family.

• Comprehensive retirement planning tools meant to maximize your savings for a secure future.

• Access to the Global Employee Assistance Programme, TELUS Health, which provides 24-hour support from a vast network of experienced professionals.

• Additional flexible benefits that may include childcare vouchers, bike purchase schemes, discounted gym memberships, travel subsidies, and health assessments.

ICON is committed to diversity, inclusion, and belonging, fostering a culture that thrives on varying perspectives and experiences. The organization offers equal employment opportunities, ensuring a workplace free from discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Conclusion

In conclusion, this remote position of Biomarker Operations Specialist at ICON is not only a significant opportunity to contribute to pioneering clinical research but also to become part of a thriving and inclusive corporate culture. The role promises challenging responsibilities and is suitable for candidates equipped with the necessary educational background and expertise in the field. Whether you're looking to advance your career in clinical operations or explore new pathways, ICON's commitment to innovation and diversity makes it an ideal place for professional growth.

This job offer was originally published on himalayas.app