Syneos Health is looking for a Project Manager - Early Phase to manage interdisciplinary clinical research studies from start to finish. You will be the primary point of contact for clients, ensuring studies are launched, conducted, and closed out on time and within budget. At Syneos Health, we are passionate about developing our people and committed to a culture where you can authentically be yourself, bringing together a diversity of thoughts, backgrounds, and perspectives.
What You'll Do
- Manage a project as the project manager overseeing interdisciplinary clinical research studies.
- Ensure compliance with GCP, relevant SOPs, and regulatory requirements.
- Act as the primary liaison between Syneos Health and the client to ensure timely study launch, conduct, and closeout.
- Lead the project team to ensure quality, timeline, and budget management.
- Account for the financial performance of each assigned project.
- Coordinate activities and deliverables of all study conduct partners while proactively identifying and managing issues.
- Account for all project deliverables for each assigned project.
- Be responsible for the quality and completeness of the Trial Master File (TMF) for assigned projects.
- Account for the maintenance of study information across various databases and systems.
- Be responsible for study management components of inspection readiness for all aspects of the study.
- Provide oversight for the development and implementation of project plans.
- Plan, coordinate, and present at internal and external meetings.
- Prepare project management reports for clients and senior management.
- Develop contingency planning and risk mitigation strategies.
- Develop strong relationships with current clients to generate new or add-on business.
- May participate in bid defense meetings where presented as the potential project manager.
- May be required to line manage other project management team members and clinical monitoring staff.
What We're Looking For
- A Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or an equivalent combination of education and experience.
- Strong knowledge of Good Clinical Practice (GCP)/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Excellent communication, presentation, and interpersonal skills, both written and spoken.
- Ability to travel as necessary (approximately 25%).
Nice to Have
- Experience working in a Clinical Research Organization (CRO).
- Relevant therapeutic area experience.
- Direct therapeutic area expertise.
- Ability to embrace new technologies.
