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.
Position Summary:
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
Requirements:
Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent
Clinical research experience as a CRA or Research Coordinator is preferred
Experience in support of business development processes; including budgets, proposals and bid defense planning and execution
Ability to work across multiple projects
Experience with renal and hepatic impairment, infectious disease and tobacco studies is an asset
Flexible and willing to travel up to 30% (regional)
Excellent problem-solving and decision making skills
Celerion Values: Integrity Trust Teamwork Respect
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.
