Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating unique clinical, medical affairs, and commercial insights into actionable outcomes, Syneos Health addresses modern market realities. With a focus on simplifying and streamlining processes, Syneos Health ensures that both customers and patients remain at the center of everything they do.
If you’re passionate about making a difference in the world of clinical research, the Central Monitor II role at Syneos Health could be the perfect opportunity for you.
Why Syneos Health?
Syneos Health is more than just a workplace—it’s a global community of 29,000 employees across 110 countries who are dedicated to changing lives. Here’s why you should consider joining the team:
- Career Development: Syneos Health is passionate about developing its people through career progression, supportive line management, and technical training.
- Total Self Culture: The company fosters an environment where you can authentically be yourself, embracing diversity of thoughts, backgrounds, and perspectives.
- Global Impact: With a presence in over 110 countries, Syneos Health has worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the past five years.
Job Responsibilities
As a Central Monitor II, you will play a critical role in ensuring the integrity of clinical trial data and patient safety. Key responsibilities include:
- Protocol Review: Understand and review protocols, identifying critical data, safety, and process risks.
- Data Analysis: Review patient data listings and visualizations to confirm eligibility, identify protocol deviations, and detect data integrity issues.
- Risk Assessment: Assess factors affecting patient safety and data integrity, such as protocol deviations and pharmacovigilance concerns.
- Communication: Escalate serious issues to the project team and develop action plans under guidance.
- Documentation: Document observations, write queries, and ensure compliance with ICH/GCP Guidelines and company SOPs.
- Vendor System Management: Verify IP administration, laboratory procedures, and eTMF data completeness.
- Project Management: Manage patient- and site-level activities to meet project objectives, budgets, and timelines.
- Training and Meetings: Attend Investigator Meetings, project staff meetings, and clinical training sessions as required.
Qualifications
To excel in this role, you’ll need:
- Experience: Minimum 1 to 2 years of relevant experience in clinical research or a related field.
- Education: Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
- Regulatory Knowledge: Familiarity with Good Clinical Practice (GCP)/ICH E6 (R2) Guidelines and other regulatory requirements.
- Technical Skills: Proficiency in MS Excel (sorting, filtering, pivoting) and analytical data visualization tools.
- Communication Skills: Excellent verbal and written communication skills to collaborate with internal stakeholders.
- Analytical Skills: Strong ability to analyze data and identify trends or issues.
- Travel: Willingness to travel <10% for trainings and investigator meetings.
Why This Role Matters
The Central Monitor II position is crucial for ensuring the success of clinical trials. By identifying and addressing data integrity issues, protocol deviations, and patient safety concerns, you’ll contribute to the development of life-changing therapies.
Join Syneos Health Today
If you’re ready to make a meaningful impact in the biopharmaceutical industry, apply for the Central Monitor II role at Syneos Health. With a commitment to diversity, career development, and global collaboration, Syneos Health is the ideal place to grow your career.
Discover what our 29,000 employees already know: Work Here Matters Everywhere.
