Lead IVD/CDx clinical programs.
Contribute to cross-functional strategy and program planning scenarios.
Proactively identify, track, manage and resolve clinical program risks and issues.
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 clinical site assessment, selection, qualification, initiation and closeout processes.
Provide clinical study site oversight.
Create and maintain study-specific and 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.

Requirements

Minimum of BS Degree in a scientific discipline with 7 years experience or MS with 5 years experience in IVD clinical studies.
Broad knowledge of key CDx deliverables including IUO clinical trial assays, sample management, data transfer/delivery, external partners, co-development bridging studies.
Understanding of Good Clinical Practices (GCP) and other relevant regulatory requirements.
Scientific writing experience (e.g., peer-reviewed publications, clinical study protocols and reports, SOPs, etc.).
Must be tolerant to change, ready to take on new challenges and open to learning in a dynamic environment.

Benefits

Highly competitive and inclusive medical, dental and vision coverage options
Health Savings Account for medical expenses and dependent care expenses
Flexible Spending Account to pay for certain out-of-pocket expenses
Paid time off, including: vacation, sick time and holidays
401k match and Financial Planning tools
LTD and STD insurance coverages, as well as voluntary benefit options
Employee Assistance Program
Pet Insurance
Legal Assistance
Tuition Assistance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical program managementclinical study oversightscientific writingdata transfersample managementprocess improvementrisk managementstudy protocol compliancetrial master file maintenanceclinical site assessment

Soft Skills

collaborationcommunicationproblem-solvingadaptabilityleadershiporganizational skillsstakeholder engagementcross-functional teamworktolerance to changeinitiative