Clinical Research

• Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
• Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
• Ensures alignment of regional deliverables with overall study goals
• Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
• Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs

Regional Clinical Study Manager

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
• Accountable for all project deliverables for each project assigned.
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct.
• Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• May participate in bid defense meetings where presented as potential project manager.

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Regional Clinical Study Manager

Clinical Trial Manager II