Clinical Project Manager

Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.  

Celerion is looking for a Clinical Project Manager who will be responsible for the independent management of multi-center site activities ensuring compliance to protocol, ICH Good Clinical Practices, Standard Operating Procedures and regulatory and local requirements.

 

This role will be home based anywhere in the United States.  Due to our international footprint, schedule flexibility is important.  This position will travel roughly 30% primarily in the US, but could include Europe on an as needed basis.

 

Essential Responsibilities:

Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements

Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline

Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans

Coordinate activities with central laboratories and other external service providers/vendors

Review and negotiate site budgets and contracts

Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets

Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.