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.
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