Clinical Project Manager

Kuros Biosurgery AG; United States; Remote; USD 100,000 - 115,000; Full time

Job summary

An innovative company in the medical device sector is seeking a Clinical Project Manager to lead clinical studies and ensure compliance with industry regulations. This remote role emphasizes strong organizational and communication skills, as well as the ability to manage clinical trial data and vendor relationships effectively. The ideal candidate will have a Bachelor's degree in a life sciences field and at least three years of experience in the medical device industry. Join a forward-thinking team dedicated to advancing biologic technologies and making a significant impact in the field of medicine.

Qualifications

• 3+ years of experience in the medical device industry required.
• Knowledge of clinical regulations and Good Clinical Practice (GCP).

Responsibilities

• Manage clinical trial data and ensure compliance with regulations.
• Train site personnel and oversee vendor management.

Skills

Clinical trial management

Communication skills

Regulatory compliance

Data management

Vendor management

Education

Bachelor's Degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

SharePoint

Microsoft Teams

Job description

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

AboutUs

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

Our credentials

With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOs TM , is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visitkurosbio.com .

• Listing on theSIX Swiss Exchangeunder the symbol KURN
• A commercial & research footprint that spans>20 markets
• 4 teams of internationally renownedclinical and scientific expert advisers
• >25orthobiologics-relatedpatents
• >400 patients evaluatedin Level I, randomized controlled clinical trials
• >20 well-controlledLevel I-III clinical trials initiated, including 6 that are complete
• Level I evidence published in Spine

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.

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