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Clinical Trials Director
2 weeks ago
About the Role
We are seeking an experienced Clinical Trials Director to join our team at Syneos Health.
Company Overview
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Approach
We bring our customers and patients to the center of everything we do, simplifying and streamlining our work to make us easier to work with and for.
Your Responsibilities
- Oversee site management, clinical monitoring, and central monitoring deliverables, prioritizing patient safety, protocol compliance, and data integrity.
- Coordinate site interactions post-activation through site closeout, including patient recruitment and investigator payments.
- Identify critical data and process risks, protocol execution risks, and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
- Review study scope of work, budget, and protocol content to ensure the clinical project team understands contractual obligations and parameters.
- Use prior clinical experience and operational data to identify risks to clinical trial management deliverables.
- Escalate risks to clinical trial management deliverables and activities out of contracted scope to the project manager.
- Employ strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participate in key meetings such as Kick Off Meetings.
- Collaborate with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
- Responsible for developing and maintaining clinical study tools and templates, ensuring CTMS, dashboards, and other systems are set up and available for use by the clinical team.
- Ensure quality of clinical monitoring, central monitoring, and site management deliverables within a project, maintaining proper visibility of its progress using approved systems and tracking tools.
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 achieving 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.
- Strong conflict resolution skills.
- Demonstrated ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
What We Offer
At Syneos Health, we offer a dynamic and collaborative environment where you can take the initiative and challenge the status quo. We strive to accelerate customer success and change lives.
Why Choose Us
Join a company that values diversity, inclusivity, and employee growth. Our Total Self culture promotes authenticity, self-expression, and respect for all individuals.
