Biomarker Consent Specialist

Job Summary

Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. As a Biomarker Consent Specialist, you’ll be joining a fast-paced, driven environment that’s helping to make life-changing differences to patients by negotiating, authoring, and reviewing genetic and biomarker language in clinical trial informed consents. Through the collaboration and diversity of teams, the Biomarker Consent Specialist is provided with multiple opportunities to excel and discover where your skills can take you.

Who We’re Looking For

• Exceptional communicator to partner effectively with internal and external teams
• Self‑motivated professional who can work independently and collaboratively
• Critical thinker able utilize and discern guidance documents as they apply to clinical trial informed consents
• Proactive problem solver to identify issues, propose solutions, and drive resolution
• Detail oriented individual with the ability to manage multiple assignments under accelerated timelines
• Quick learner who can become proficient in client tools, databases, and systems
• Proficient MS Office Suite user

What You’ll Do

• Author, review, and negotiate genetic and biomarker language within clinical trial informed consent documents
• Document restrictions related to genetic and biomarker research on clinical trial samples
• Understand and apply company policies and procedures to ensure consistency and compliance in informed consent language
• Collaborate with global stakeholders to negotiate informed consents across multiple regions
• Utilize clinical trial systems (eTMF, LIMS, etc.) to support documentation and workflow needs
• Manage multiple concurrent assignments while meeting accelerated project timelines
• Provide clear communication and partnership to cross‑functional teams to achieve study and organizational goals

Qualifications

A Bachelor’s degree (BA/BS) is required, along with a minimum of 5 years of experience working with global clinical trials and associated systems (eTMF, LIMS, or similar). Proven experience with genetic informed consents and global consent negotiation is also essential for this role.

Why Join Parexel

Be part of groundbreaking projects that are pushing the boundaries of the industry. Experience a collaborative and inclusive work environment that highly appreciates your expertise. Unlock your full potential with professional growth and development opportunities. Enjoy work life balance and flexible working hours.

Parexel US Benefits

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance

Additional Information

At Parexel, we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you’re exposed to a world of experiences and open doors.

Key skills/competency

• Biomarker Consent
• Genetic Language Negotiation
• Clinical Trial Compliance
• Regulatory Affairs
• Informed Consent Documents
• eTMF & LIMS
• Global Stakeholder Collaboration
• Project Management
• Cross-functional Communication
• Policy Application