Clinical Project Manager

The Clinical Project Manager will report to the Senior Director of Clinical Affairs and manage Clinical Research Associates as part of the Clinical Affairs Team. This remote position, available within 80 miles of a major U.S. airport, requires a highly organized individual with strong communication skills and attention to detail. The role involves leading clinical studies in compliance with Good Clinical Practice (GCP), local regulations, and company standards. Key responsibilities include managing clinical trial data, reviewing study documents, supporting clinical sites, and ensuring regulatory compliance. The position also involves vendor management, training site personnel, monitoring project timelines, and addressing study risks or issues. A bachelor's degree in a life sciences field and at least 3 years of experience in the medical device industry are required, along with knowledge of clinical regulations, excellent communication skills, and the ability to work independently. A Project Management Professional (PMP) certification is desirable. Travel up to 15% of the time is expected, and staying updated on scientific research is a key part of the role.

Key Responsibilities:

• Clinical trial data management and support of sites.
• Assist in the development of CRFs and other study related documents.
• Independently review eCRFs and reports, ensuring that clinical trials are being conducted in accordance with protocols, GCP, ICH, SOP's and regulations (FDA/DEA).
• Review and approve reports from site qualification visits, site monitoring visits and study close out visits. Provide support to the site staff in case of audits or inspections. Following up with clinical sites to ensure accuracy, integrity and completeness of the study data.
• Managing regulatory documents and maintaining regulatory compliance, reviewing data entered into the EDC.
• Oversee the contracting and management of vendors and ensure expectations are met.
• Training of site personnel, identifying study related issues and escalating as needed.
• Ensure the set up and maintenance of project plans are in compliance with company policies and timelines.
• Identify, address and/or escalate study related risks, issues, mitigations, and opportunities for improvements.
• Review and track clinical invoices.
• Engage with Key Opinion Leaders (KOLs) in the fields of medicine or research.
• Stay informed on the latest scientific research and clinical data relevant to Kuros Biosciences.
• Ability to travel between 15% of the time.
  
  

Qualifications:

• Bachelor's Degree in a life sciences field, (science related discipline preferred).
• Minimum 3 years medical device industry experience. Experience in managing clinical trials whether by Sponsor and/or CRO, and on-site monitoring experience is required.
• The highest ethical standards, specifically surrounding protected medical information and clinical research.
• Working knowledge of relevant clinical regulations and industry standards including Good Clinical Research Practice, ICH, ISO, FDA and the MedTech EU Code of Practice.
• Excellent verbal and written communication skills (protocols, reports, correspondence, etc.)
• Proficiency in Word, Excel, PowerPoint, SharePoint, Microsoft Teams, etc.
  
  

Pay Range

$100,000—$115,000 USD

About Us

Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.

Our credentials

Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016. With additional operations in the Netherlands and the USA, we continue to grow our global team. To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to reduce fusion failures.

• Listing on the SIX Swiss Exchange under the symbol KURN
• A commercial & research footprint that spans >20 markets
• 4 teams of internationally renowned clinical and scientific expert advisers
• >25 orthobiologics-related patents
• >400 patients evaluated in Level I, randomized controlled clinical trials
• 10 well-controlled Level I-III clinical trials initiated, including 6 that are complete*
  
  

Today, nearly 1 in 5 spinal fusions fail. But what can we do to change this situation - for the benefit of patients, surgeons, and our wider society? This is the question that drives us at Kuros. Every day our team works across three continents to unlock the hidden secrets of bone healing through our research, development & technology program: Project Fusion. To deliver the ideal bone graft, we believe you need the highest quality & quantity of scientific evidence behind it. Which is why Project Fusion brings together an unprecedented blend of scientific, pre-clinical and clinical studies – all aimed at making the unpredictable…predictable.

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.