Clinical Trial Manager II (monitoring exp. REQUIRED)

Syneos Health, Inc.; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Clinical Trial Manager II. This role involves overseeing clinical trials, ensuring compliance, and managing site interactions. Ideal candidates will have a strong background in clinical trial management and leadership experience. Join a team dedicated to accelerating therapy delivery and making a difference in patients' lives.

Qualifications

• Experience in site management and monitoring, preferably risk-based.
• Knowledge of clinical trial management, GCP, and regulations.

Responsibilities

• Oversee site management, clinical monitoring, and data integrity.
• Identify risks related to data and develop mitigation strategies.
• Train study teams on protocols and data collection.

Skills

Leadership

Communication

Conflict Resolution

Problem Solving

Education

Bachelor’s degree or RN

Job description

Clinical Trial Manager II (monitoring exp. REQUIRED)

Updated: May 17, 2025
Location: United States
Job ID:24006480

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers on the customer and the patient. We continually seek to simplify and streamline our work to make Syneos Health a better place to work and collaborate.

Whether in a Functional Service Provider partnership or a Full-Service environment, you will work with passionate problem solvers to help our clients achieve their goals. We are agile and dedicated to accelerating therapy delivery because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are committed to developing our people through career growth, supportive management, training, recognition, and rewards.
• We foster a Total Self culture where authenticity is valued, and we prioritize employee well-being.
• We embrace diversity of thought, background, and culture to create an inclusive workplace where everyone belongs.

Job Responsibilities

1. Oversee site management, clinical monitoring, and central monitoring focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity.
2. Manage site interactions from activation through closeout, including recruitment and investigator payments.
3. Identify risks related to data and process, and develop mitigation strategies.
4. Review study scope, budget, and protocol, ensuring team awareness of contractual obligations.
5. Use operational data and metrics to identify potential risks to trial management.
6. Escalate issues to project management and propose solutions.
7. Participate in key meetings and serve as a point of contact for investigator communications.
8. Coordinate with functional teams to meet study milestones and review related plans.
9. Develop and maintain study tools, templates, and systems, including UAT and access controls.
10. Train study teams on protocols, data collection, and systems.
11. Manage resource allocations and monitor team conduct and study progress.
12. Review monitoring documentation to ensure quality and compliance.
13. Interact with clients and internal teams to provide status updates and resolve issues.
14. Support inspection readiness and compliance with regulations.
15. Supervise CRAs and monitors, assessing performance and addressing risks.
16. Provide performance feedback to staff and support training and development.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Leadership experience in project milestones and team management.
• Experience in site management and monitoring, preferably risk-based.
• Knowledge of clinical trial management, GCP, and regulations.
• Strong computer, communication, and conflict resolution skills.
• Ability to solve complex problems using a risk management approach.
• Willingness to travel approximately 20%.

Get to Know Syneos Health

In the past 5 years, we have worked with 94% of FDA-approved drugs, 95% of EMA-approved products, and conducted over 200 studies across 73,000 sites with 675,000+ patients.

Every role here involves initiative and challenging the status quo in a dynamic environment. Learn more about Syneos Health.

Additional Information

Tasks and responsibilities are not exhaustive and may change. Equivalent experience and skills will be considered. We are committed to compliance with applicable laws and promoting an inclusive, accessible workplace.