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Precision for Medicine is seeking a Clinical Trial Manager to lead and manage clinical teams on assigned studies, ensuring timeline adherence, project scope management, and quality delivery. This role is ideal for high-energy professionals who thrive in dynamic environments and take charge of complex clinical trial operations.
Key Responsibilities:
- Lead and manage clinical teams on studies, overseeing timeline adherence and project scope while maintaining quality standards
- Manage operational delivery of clinical trial elements including site feasibility and selection, start-up, clinical plans and document development, subject enrollment, site engagement and support, monitoring planning and execution, resourcing, regulatory documentation, data cleaning, and close-out
- Ensure successful execution of assigned trials and completion of trial deliverables
- Maintain appropriate communication and ongoing oversight of assigned trials through close collaboration with sponsors and functional team members
- Participate in and present at sponsor meetings including bid defenses, kick-off meetings, investigator meetings, and face-to-face meetings
- Mentor and train team members, including Clinical Research Associates (CRAs)
- Lead CRAs in establishing relationships with trial sites for high-quality oversight of monitoring, regulatory, intellectual property, and site correspondence activities
- Identify challenges to study timelines and deliverables, offering creative action plans to the team and sponsor
- Contribute to company and department initiatives to strengthen processes and procedures
Required Qualifications:
- Bachelor's degree or equivalent in science or health-related field
- Minimum 5 years of clinical research experience with significant clinical monitoring experience (Clinical Trial Lead/Manager track) or 7 years (Senior track)
- Preferred: 2+ years of CTM experience at a CRO, pharma, or biotech company (4+ years for senior level)
- Moderate independent field monitoring experience
- Clinical team lead or comparable supervisory experience
- Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Experience with EDC and eTMF systems
- Excellent communication and interpersonal skills
- Strong organizational skills, attention to detail, and customer service orientation
- Availability for domestic and international travel
- Demonstrated knowledge of ICH-GCP and regulatory guidance
- Understanding of therapeutic areas, medical terminology, and clinical trial activities
