Clinical Study Manager (Senior)
Contract Type: 18month fixed term contract with potential for extension
Location: Remote (Work from Home)
Strong preference for candidates based on the U.S. East Coast (e.g., Boston area) to support collaboration with key stakeholders in Denmark and other parts of Europe.
Role Overview
We are seeking an experienced Senior Clinical Study Manager to provide operational and oversight of a validation study within the IVD space. This is a desk based, senior role focused on managing and overseeing daily study activities, ensuring execution excellence, compliance, and high quality clinical deliverables.
The role will work closely with Clinical Affairs leadership and cross functional partners, acting as a key operational lead for the study.
Key Responsibilities
- Provide day-to-day oversight of clinical validation study activities
- Lead and coordinate operational execution of the clinical study, ensuring timelines, quality, and compliance
- Serve as the primary point of contact for clinical operations activities
- Oversee interactions with clinical sites, and external partners
- Ensure study conducts aligns with regulatory requirements and internal SOPs
- Review and manage clinical documentation, reports, and study deliverables
- Identify operational risks and proactively drive mitigation strategies
- Support Clinical Affairs leadership with study updates, issue escalation, and decision support
- Collaborate cross functionally with Regulatory, Quality, R&D, and external vendors as required
Ideal Candidate Profile
Required Experience & Skills
- Senior level experience in clinical study management or clinical operations
- Strong background in IVD clinical studies, including validation studies
- Proven operational oversight experience in desk based clinical roles
- Laboratory experience (direct or through close collaboration with labs)
- Solid understanding of clinical study processes, documentation, and compliance
- Ability to work independently in a remote environment while managing multiple stakeholders
- Strong organizational, communication, and problem-solving skills
Preferred Qualifications
- Prior experience managing or supporting IVD studies
- Familiarity with U.S. clinical and laboratory environments
- Availability within U.S. East Coast time zones for collaboration purposes
About Us
BioPorto is a global leader in innovative diagnostic solutions for kidney health, committed to improving patient outcomes through cutting-edge science.
We use our antibody and assay expertise to transform novel research tools into clinically actionable biomarkers that can make a difference in patients’ lives.
BioPorto is headquartered in Hellerup, Denmark, and has facilities in Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information, visit www.bioporto.com.
Ready to Make Your Mark?
Apply now by uploading your CV and a short cover letter using the Careers form. All inquiries will be handled confidentially.
Interviews will be performed in parallel to the application period. We reserve the right to proceed with the employment process if the right candidate is identified during this period.
BioPorto provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
