Senior Clinical Project Manager

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

The Senior Clinical Project Manager reports directly to the Director Clinical Affairs and plays a critical role within TMC. This individual will lead all of the Company’s clinical research projects including strategy, execution, and budgetary planning and management. 

As the Clinical Affairs Project Manager, you will work closely with the Company’s marketing staff, KOLs, investigating physicians, and clinical research operations personnel (contractors), to manage all aspects of the company’s clinical studies, including assessing operational feasibility and recommending study execution plans; developing and managing comprehensive study timelines and metrics; overseeing the selection and management/oversight of external vendors while developing vendor specifications; reviewing vendor reports, budgets and metrics; preparing and presenting project debriefings as required; planning, executing, and leading study-specific meetings; and managing/participating in site-monitoring visits. 

You will be a hands-on leader and the point of contact for clinical trial sites. Will monitor and drive enrollment in studies, provide site screening and initiations, and interact directly with contracted monitoring and data management organizations, where utilized. You may also be involved in preparation of submissions to the FDA. 

What you will be responsible for: 

• Manage and oversees multiple clinical studies and the multidisciplinary clinical study team  

• Identify clinical sites and establishes relationships with potential Principal Investigators 

• Work directly with customers to validate the clinical value of the product (work on on-going trials and initiate trials with customer) 

• Support clinical research-related procedures 

• Develop Protocols, informed consent forms and other clinical study documents 

• Prepare IRB submissions to obtain the necessary approvals 

• Ensure study implementation, including site staff training, data collection, and oversees study progress 

• Perform study monitoring visits (qualification, initiation, interim and close-out) as needed 

• Review and approve of study monitoring visit letters and reports 

• Perform data analysis, generates reports, and archives data 

• Provide feedback to product management for User Requirements generation and validation based on interfacing with clinical users 

• Create and tracks clinicals study plans and budgets 

• Ensure compliance with regulations (e.g. FDA, ISO, ICH) and Good Clinical Practices (GCPs) 

• Bachelor’s degree 

• Seven (7) years of experience as Clinical Research Associate, actively monitoring clinical research projects. 

• Seven (7) years of experience as a Program/project manager and/or process improvement in clinical research or healthcare 

• Experience in MS Project (or similar scheduling software), Smart Sheets,  project management techniques and tools, Excel, PowerPoint, and Word 

• Project Management Professional (PMP), Project Management Certification (preferably PMI) a plus  

All your information will be kept confidential according to EEO guidelines.

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