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Clinical Research Project Manager
1 week ago
Syneos Health, Inc. is a leading integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with, and to make us easier to work for.
Clinical Leadership and Delivery:
Manage projects as a project manager overseeing interdisciplinary clinical research studies.
Ensure compliance with GCP, relevant SOP's, and regulatory requirements.
Act as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout.
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.
Demanding Quality and Reporting:
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.
New Business Development:
Develop 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.
Management:
May be required to line manage other project management team members and clinical monitoring staff.