Job Description
Our client is a fast-growing, global medical device company focusing on non-invasive treatments for some of the most challenging diseases.
They are looking for a Clinical Project Manager to support global trials.
Requirements
Bachelor’s degree in the science field. Advanced degree preferred.
Minimum 3 years of experience as a Clinical Project Manager with PMA Class III device process.
Minimum 5 years of US and global regulatory/clinical trial experience in the medical device industry including experience executing feasibility, pivotal, and post-market approved trials.
Experience with global regulatory processes /various international clinical trials.
Experience writing clinical trial documents including protocols, amendments, and clinical study reports
Demonstrates strong database management skills, including descriptive data analysis
Knowledge of financial principles in budgeting and tracking of clinical trials and effective management of assigned internal and external resources
In-depth knowledge of global clinical trial processes and regulations
Demonstrates current working knowledge of all phases of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with clinical trials.
Able and willing to travel as needed, including international travel (20%)
Responsibilities:
Manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (ICHGCPs) and in compliance with appropriate company Standard Operating Procedures (SOPs) as applicable under the Regulatory Agency(ies) governing the study, and any other applicable guidelines and regulations.
Responsible for clinical operational oversight and execution of assigned trial(s) in order to achieve expectations of quality, timelines and budget, and study conduct.
Manage successful Clinical Research and Clinical Trials submissions (as needed) to governing Regulatory Agency(ies) in full compliance with local regulatory laws
Builds and sustains extensive global networks across multiple functions at study team level.
Develop and share best practices to accelerate project timelines
Manage relationships with internal CRO and external site personnel, vendors, key opinion leaders, sub-contractors and applicable regulatory agencies.