Clinical Research Manager

Voltaire Clinical Research is a patient-centered clinical research organization dedicated to advancing medical innovation through the successful execution of high-quality clinical trials across a broad range of therapeutic areas. We partner with sponsors, CROs, and healthcare providers to bring new treatments to patients while maintaining the highest standards of scientific integrity, regulatory compliance, and participant care.

We are seeking an experienced and motivated Research Manager to lead the day-to-day operations of our clinical research programs. This leadership role is responsible for overseeing study execution, managing research staff, ensuring regulatory compliance, and driving operational excellence across multiple clinical trials. The ideal candidate is a proactive leader with strong organizational, communication, and problem-solving skills who is passionate about advancing clinical research and delivering exceptional patient care.

Key Responsibilities

• Oversee the daily operations of multiple clinical research studies from study start-up through closeout.
• Supervise, mentor, and support Clinical Research Coordinators and research staff to ensure high-quality study execution.
• Ensure compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and institutional policies.
• Manage study timelines, enrollment goals, subject retention, and sponsor deliverables.
• Coordinate study start-up activities, including feasibility assessments, site initiation visits, and regulatory submissions.
• Serve as the primary point of contact for sponsors, CROs, monitors, investigators, and regulatory agencies.
• Review informed consent documentation, source documentation, case report forms, and regulatory binders for accuracy and completeness.
• Lead quality assurance initiatives, prepare for sponsor audits and regulatory inspections, and implement corrective and preventive actions as needed.
• Develop and maintain standard operating procedures (SOPs) and ensure staff receive ongoing training.
• Foster a patient-centered environment that prioritizes participant safety, confidentiality, and engagement.
• Identify opportunities to improve workflow efficiency and support business growth through operational excellence.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Healthcare Administration, or a related field (Master's degree preferred).
• Minimum of 5 years of clinical research experience, including leadership or management responsibilities.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical research operations.
• Experience managing multiple studies across various therapeutic areas.
• Excellent leadership, organizational, and project management skills.
• Strong communication and interpersonal abilities with experience working directly with sponsors and CROs.
• Proficiency with electronic data capture (EDC) systems, CTMS, and Microsoft Office applications.
• ACRC, CCRP, CCRC, or equivalent clinical research certification is preferred.

What We Offer

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and leadership development.
• Collaborative, patient-focused work environment.
• The opportunity to contribute to innovative clinical research that improves patient outcomes across diverse therapeutic areas.

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person