Clinical Trial Manager

Shoulder Innovations is a venture-backed medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, we've developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth.

We're seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on:

• People First: Authentically human.
• One Team: Empowered and aligned.
• Innovation: Bold, creative, and daring.
• Growth Mindset: Always curious.

Ready to make an impact in orthopedics? Let's grow together!

We are seeking a Clinical Trial Manager who wants to use their knowledge to help grow our venture capital-backed business. Someone who is experienced in clinical trials, registry, very organized, and a strong self-starter would be a
perfect fit.

As a Clinical Trial Manager, some of your job duties will include:

• Manage the planning, execution and monitoring of clinical trials to ensue adherence to timelines
• Develop and maintain trial documentation including protocols, informed consent forms, and study reports.
• Ensure clinical studies are compliant with ICH/GCP, FDA regulations and other regulations, as appropriate, throughout the trial process
• Oversees data collection processes to ensure accuracy and integrity of trial data
• Participates in site selection, monitoring and close-out visits as necessary
• Provide training and support to site staff on study protocols and procedures
• Analyze trial data and prepare reports for stakeholders
• Participate in continuous improvement activities

To be successful as a Clinical Trial Manager, you will have the following experiences and skills

• Minimum Bachelor's degree in scientific discipline and 7+ years of related work experience or an equivalent combination of education and work experience
• Minimum 2+ years of Independent Clinical Trial Management preferred
• Proven experience with registries preferred
• Proven experience with shoulder arthroplasty or orthopedics preferred
• Familiarity with clinical development standards and regulatory requirements (GCP, FDA)
• Strong knowledge of clinical trials management principles and practices
• Proficiency in data collection methodologies and data management
• Detail-orientated with the ability to multi-task
• Exceptional drive, work ethic and initiative
• Energetic and enthusiastic personality who thrives on diversity and challenge in a role
• Must be able to work collaboratively and operate in a fast-paced environment
• Strong working knowledge of MS Office
• Excellent analytical and problem-solving skills
• Proficient written and verbal communication skills

If you believe that you are a perfect fit to join our team as a Clinical Trial Manager, please consider applying today. To learn more about what Shoulder Innovations does, please visit us at www.shoulderinnovations.com.