We are seeking an experienced and skilled Clinical Trial Manager (CTM) to join our team at
Pace Pharm. As a CTM, you will be responsible for overseeing the planning, execution, and
delivery of clinical trials, ensuring compliance with regulatory requirements, and driving the
success of our clinical research programs.
Key Responsibilities
Trial Management
- Manage and coordinate clinical trials from concept to completion, including study, start-up, patient recruitment, data collection, and study close-out
- Develop and implement clinical trial plans, protocols, and procedures
- Collaborate with cross-functional teams, including investigators, research staff, and sponsors
Compliance and Quality
- Ensure compliance with GCP, FDA regulations, and ICH guidelines
- Oversee study budgeting, forecasting, and financial management
- Develop and manage study timelines, milestones, and deliverables
- Conduct site initiation, monitoring, and close-out visits
- Manage and resolve study-related issues and deviations
Leadership and Collaboration
- Lead and mentor a team of Clinical Research Associates (CRAs)
- Develop and implement training programs for new staff members
- Collaborate with data management teams to ensure data quality and integrity
- Participate in the development of clinical trial protocols and amendments
Risk Management and Documentation
- Conduct risk assessments and develop mitigation plans
- Ensure compliance with company SOPs and regulatory requirements
- Manage and maintain study documentation and records
- Collaborate with regulatory affairs teams to ensure compliance with regulatory requirements
Requirements:
- Bachelor’s degree or higher in a life science or related field
- Minimum 3-5 years of experience in clinical research, management, or a related field
- Strong knowledge of GCP, FDA regulations, and ICH guidelines
- Excellent leadership, communication, and problem-solving skills
- Ability to work independently and as part of a team
- Basic computer skills and familiarity with electronic data capture systems
- Certification as a CCRA, CCRP, or CTM preferred
Benefits:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance
- Comprehensive training and mentorship programs
- Flexible work arrangements and remote work options
- 401(k) retirement plan with company match
- Health, dental, and vision insurance
- Life insurance and disability benefits
- Paid time off and holidays
- Employee stock options
- Professional membership and conference fees reimbursement
- Access to cutting-edge technologies and tools
What We Offer:
- A dedicated CTM mentorship program to support your professional development
- Opportunities to work on a variety of clinical trials across different therapeutic areas
- A comprehensive study management system to streamline your work and enhance productivity
- A collaborative team environment with regular feedback and support
- A chance to contribute to the development of innovative treatments and improve patient outcomes
- A flexible work schedule to accommodate your needs and promote work-life balance
Equal Employment Opportunity
Pace Pharm is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.