Clinical Program Manager

About the role

Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

Main Purpose of the Role

The CPM Clinical Program Manager (CPM) will plan, initiate, and execute regional and global clinical studies and projects in orthopedic devices and biologics, ensuring delivery against scope, timeline, budget, quality and applicable regulatory requirements. The CPM will contribute to planning of medium-long term clinical evidence generation initiatives. The CPM will have a high level of interaction with the study team, internal stakeholders, study sites, and vendors.

Key Responsibilities

• Establish the study/project team goals and lead each phase of the life cycle of the assigned studies/projects to ensure completion in compliance with Bioventus SOPs and applicable GCP/ICH guidelines and other regulatory requirements
• Provide accurate and up-to-date study/project information and metrics to management; proactively identify and resolve issues that arise during regional and global study conduct; manage escalation of study/project-related issues
• Study Documents: accountable for all study documents for assigned studies/projects; and may assist with preparing key documents such as, ICF Investigator Brochure, FDA Briefing Documents, internal/external presentations, etc., develop and approve study plans
• Assist the Director Clinical Affairs in protocol development including but not limited to review of relevant literature, liaison with external subject matter experts, and drafting of initial versions.
• Monitor study/project execution against protocol intent and suggest amendments as necessary with contribution toward development of desired amendments
• Oversee the financial life cycle of the study execution including site budgets, study budgets, study forecasting and invoice reconciling. With reporting and tracking of study financial activities from patient, site, and vendor details via the use of CTMS and/or Excel files.
• Contribute insights with respect to timely data cleaning, data analysis and the availability of top line results through