Clinical Project Manager

ZipRecruiter; Sandy Springs (GA); Remote; USD 100,000 - 115,000; Full time

Job summary

A leading company in the medical device industry is seeking a Clinical Project Manager to oversee clinical trials and ensure compliance with regulations. This remote role requires strong organizational skills and at least 3 years of relevant experience. The successful candidate will manage data, support clinical sites, and maintain regulatory standards while collaborating with various stakeholders.

Qualifications

• Minimum 3 years medical device industry experience required.
• Experience in managing clinical trials and on-site monitoring is necessary.

Responsibilities

• Manage clinical trial data and ensure regulatory compliance.
• Oversee vendor management and train site personnel.
• Identify and address study-related risks and issues.

Skills

Communication

Attention to Detail

Education

Bachelor's Degree in a life sciences field

Tools

Word

Excel

PowerPoint

SharePoint

Microsoft Teams

Job description

Job DescriptionJob 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 ).
• 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

Physical Requirements and Work Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items up to 50 pounds, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver's license.

Specific requirements may vary by role. Contact an HR representative for details related to the position.

About Us

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, MagnetOsTM, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.

• 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
• >20 well-controlled Level 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 and in the workplace. We prohibit discrimination and harassment of any kind based on , , , , , , , genetic information, , 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.