Clinical Project Manager II - Early Phase/Site Evaluation
Updated: November 11, 2024
Location: United States (Home-Based)
Job ID: 24006185
Position Overview
This hybrid role at Syneos Health combines Clinical Project Management and Senior Clinical Research Associate (CRA) responsibilities. It supports Early Phase clinical trials with a focus on project management tasks and clinical site evaluation. This role is Sponsor-dedicated, allowing you to work remotely in the U.S., with up to 50% travel required.
Key Responsibilities
Project Leadership and Delivery
Manage interdisciplinary clinical research projects, ensuring compliance with GCP guidelines, SOPs, and regulatory requirements.
Act as the primary liaison between the Sponsor and Syneos Health for project timelines, study launches, and closeouts.
Lead project teams to ensure deliverables meet quality, budget, and timeline expectations.
Coordinate activities across study partners and proactively address potential challenges.
Ensure compliance with all relevant regulations and oversee project financial performance.
Documentation and Reporting
Maintain the Trial Master File (TMF) and ensure its completeness for all projects.
Oversee study data management across databases and systems.
Prepare project plans, management reports, and inspection readiness components.
Present at internal and external meetings to provide updates and discuss project progress.
Business Development
Build strong client relationships to promote future/add-on business opportunities.
Participate in bid defense meetings when presented as the project lead.
Management
Line-manage other project team members and clinical monitoring staff, as required.
Support contingency planning and develop risk mitigation strategies for project success.
Qualifications
Education and Experience
Bachelor’s Degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent education/experience.
Prior Senior CRA experience required, with Early Phase trial expertise highly preferred.
Strong knowledge of ICH/GCP guidelines and other regulatory requirements.
Previous experience in Pharma/CRO Project Management.
Skills
Proficient in time management and organizational skills, with the ability to work independently.
Expertise in therapeutic area practices and research methodologies.
Excellent written and verbal communication, presentation, and interpersonal skills.
Ability to adapt to and adopt new technologies.
Ability to travel frequently (up to 50% travel required).
Why Join Syneos Health?
Syneos Health is a leading biopharmaceutical solutions company, partnering with 94% of FDA-approved novel drugs over the past five years. The company emphasizes innovation, collaboration, and the accelerated delivery of therapies to patients.
Benefits
Health insurance (medical, dental, vision).
401(k) match and Employee Stock Purchase Plan eligibility.
Flexible Paid Time Off (PTO) and sick leave.
Potential for a company car or car allowance.
Bonus/commission opportunities based on individual and company performance.
Compensation
Base Salary Range: $85,500 - $175,700, depending on experience and qualifications.
This role is ideal for experienced clinical professionals passionate about advancing Early Phase research and developing innovative therapies. Syneos Health fosters an inclusive, supportive environment with opportunities for career progression and global collaboration.
If you're interested in shaping the future of clinical research, apply today!
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