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We are seeking a hands-on Clinical Trial Manager to oversee clinical trial operations and drive study execution from start-up through closeout. This role requires strong sponsor management skills, accountability for study outcomes, and the ability to thrive in a fast-paced, collaborative environment.
Job Responsibility:
Reviews, and may also contribute to the development of, clinical study-related documents
Helps to ensure that the study is conducted in accordance with agreed upon timelines
Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study
Contributes to the planning and coordination of investigator meetings
Maintains relationships with assigned investigator sites, vendors and consultants
Ensures investigator and investigator site personnel comply with protocols
Assists in the oversight of the shipment of, and return of, clinical supplies
Maintains accurate and updated study files
Participates in the selection and oversight of external service providers
Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency
Assists in configuration and implementation of study-related systems
Performs other tasks and assignments as needed and specified by management
Requirements:
5+ years of clinical trial coordination/management experience
Global clinical trial experience required
Strong understanding of drug development processes
Strong project management and organizational skills
In-depth knowledge of FDA and ICH GCP guidelines
Excellent communication and stakeholder management abilities
Proactive, hands-on approach with willingness to wear multiple hats
Previous clinical monitoring experience
Experience with Microsoft PowerPoint
Bachelor’s degree in a science or clinical-related field required