Clinical Trial Manager II
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Job Description
Clinical Trial Manager overseeing Phase 1 clinical research studies for Syneos Health. Collaborating with cross-functional teams to ensure patient safety and regulatory compliance.
Responsibilities:
- roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities.
- Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage.
- Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.
- Impact and Contribution Includes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization.
- Supervises experienced support employees and/or entry individual contributors.
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Requirements:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Demonstrated ability to lead and align teams in the achievement of project milestones
- Demonstrated capability of working in an international environment.
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
Benefits:
- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself
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