Senior Clinical Project Manager - Denmark

Our company is a lead CRO for Biotech companies and is continuing to add Clinical Trial Managers of different experience levels to join our Clinical Trial Management Group in our European locations. Clinical Trial Managers with expertise in Oncology/Hematology, Cardiovascular, Infectious Disease, CNS, Neuroscience, and Immunology are welcome to continue to work in their area of expertise or to expand to a new therapeutic area. We provide remote flexibility only with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates.

Reponsibilites

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables
• Maintain in depth knowledge of protocol, therapeutic area, and indication
• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
• Develop operational project plans
• Manage risk assessment and execution
• Responsible for management of study vendor
• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables

Qualifications 

• Bachelor’s degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred;
• Experience in Phases 1-4; Phases 2-3 preferred;
• Minimum of 2 years of Clinical Trial Management experience, CRO experience preferred;
• 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required for a remote-based role;
• Management of overall project timeline;
• Bid defense experience preferred; and
• Strong leadership skills.