Clinical Project Manager II
hace 2 meses
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model puts the customer and patient at the center of everything we do. We continuously seek ways to simplify and streamline our work.
Key Responsibilities:
- Manage projects as a project manager, overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
- Act 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 teams 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 SOPs, and regulatory requirements.
- Accountable for all project deliverables for each project assigned.
Documentation and Reporting:
- Responsible for the quality and completeness of the Trial Master File (TMF) for assigned projects.
- Accountable for maintaining study information on various databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for developing and implementing project plans.
- Plan, coordinate, and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
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 a potential project manager.
Management:
- May be required to line manage other project management team members and clinical monitoring staff.
Qualifications:
- Bachelor's Degree (or equivalent) level of qualification in life sciences, medicine, pharmacy, nursing, or an equivalent combination of education and experience.
- Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Direct therapeutic area expertise.
- Ability to embrace new technologies.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Ability to travel as necessary (approximately 25%).
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway.
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