Clinical Research Operations Manager
4 days ago
Job Overview
Flourish Research is a leading integrated clinical research site company in the US, with a strong brand and track-record of recruiting and retaining a highly diversified patient population. We are seeking an experienced Clinical Research Operations Manager to lead our Boca Raton, FL location.
About the Role
- Responsible for executing and overseeing operational functions, including P&L, and driving business planning to achieve margin/EBITDA targets.
- Leverage expertise in clinical trial management to ensure successful execution of studies, from start-up to close-out.
- Collaborate with cross-functional teams to implement Standard Operating Procedures (SOPs) and policies to ensure compliance with Good Clinical Practices, federal regulations/ICH guidelines, HIPAA laws, and sponsor protocols.
- Maintain high-level involvement by principal investigators as required by FDA regulations/ICH guidelines and SOPs through frequent communications and coordination of training.
- Ensure data integrity by working closely with Quality Control (QC) for timely submission of quality data to sponsors.
- Establish and manage effective patient acquisition programs to ensure successful enrollment of clinical trials at the site.
Requirements
- Bachelor's degree and minimum of 5 years' experience in clinical research, specifically working on industry-sponsored clinical trials.
- Minimum 2 years' experience leading teams and managing direct reports, preferably site-level leaders.
- Experience with clinical trial start-up, regulatory preparation, recruitment, and clinical preparation to successfully initiate and execute studies.
- Experience hosting audits and/or inspections.
- Multitherapeutic experience preferred, with ideal experience in therapeutic areas such as cardiology, endocrinology, metabolic disorders, vaccines, neurology, psychiatry, or women's health.
- Strong leadership, team-building attributes, and problem-solving skills.
What We Offer
- Estimated salary range: $100,000 - $130,000 per year, plus 20% bonus potential.
- Annual Performance-Based Merit Salary program.
- Paid Time Off.
- 8 Paid holidays, Additional 2 Floating Holidays.
- 401K plan: 4% Match.
- Employee Review and Performance Program.
- Tuition Reimbursement Policy.
- Employee Referral Bonus.
- Supplemental Parental Leave.
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