Global Companion Diagnostics Specialist

Role Summary

The Global Companion Diagnostics Specialist is a key contributor in the Translational Science team responsible for supporting companion diagnostic and in vitro diagnostic product development lifecycle strategies to support global marketing authorizations. This includes clinical programs with focused attention on Design Controls and Good Clinical Practices for clinical performance studies. The Global Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs and other study stakeholders to coordinate study-related activities that are tailored to specific marketing applications. Additional responsibilities include creating study-specific and departmental documentation including but not limited to SOPs, templates, forms, plans, protocols and reports through close collaboration with the appropriate cross-functional teams. The Global Companion Diagnostics Specialist will support clinical study compliance through creation and maintenance of trial master files, study tracking and leading meetings with the study personnel.

Responsibilities

• Support, manage and/or coordinate IVD/CDx clinical study activities.
• Clinical study representative for project and study teams.
• Facilitate internal and external clinical study preparation and planning meetings.
• Collaborate and communicate with study personnel and stakeholders.
• Ensure study protocol, GCP, regulatory and SOP compliance.
• Participate in site assessment, selection, qualification, initiation and closeout processes.
• Provide clinical study site oversight.
• Real-time escalation of clinical studies risks and issues to management.
• Create and maintain trial master files.
• Contribute to and/or lead process improvements.
• Socialize regulatory requirements and standards (e.g., FDA, ICH GCP, ISO 20916, IVDR, MDCG) with cross-functional teams and study personnel.
• Accepts other duties as assigned.

Qualifications

• Required: Minimum BS Degree in a scientific discipline with 3+ years of experience in IVD clinical studies.
• Required: Understanding of Good Clinical Practices (GCP) and other relevant regulatory requirements
• Required: Scientific writing experience (e.g., peer-reviewed publications, SOPs, etc.).
• Required: Must be tolerant to change, ready to take on new challenges and open to learning in a dynamic environment.
• Preferred: Master’s Degree in a scientific discipline with 3+ years of experience in IVD clinical studies.
• Preferred: Knowledge of Next Generation Sequencing.
• Preferred: Experience in CDx and/or precision medicine.
• Preferred: Design for Six Sigma and/or other process methodology tools training.
• Preferred: Certification as a Clinical Research Professional.

Skills

• Clinical study coordination
• Regulatory and GCP compliance
• Clinical writing and documentation
• Cross-functional collaboration
• Study master file management
• Risk identification and escalation

Education

• BS in a scientific discipline (Required)
• MS in a scientific discipline (Preferred)

Additional Requirements

• This position requires periodic travel and some evenings, weekends and/or holidays.
• At times may be required to work weekends/holidays.