Clinical Trial Manager
Salary: $150,000-$165,000
This biotech is leading company focused on developing innovative therapies for rare diseases. Their mission is to bring life-changing treatments to patients who have few or no options. They are a dynamic and fast-growing company with a collaborative and inclusive culture.
Position Overview: They are seeking a highly motivated and experienced Clinical Trial Manager (CTM) to join their Clinical Operations team. The CTM will be responsible for managing all aspects of clinical trials, ensuring they are conducted in accordance with regulatory requirements and company objectives. This role will involve close collaboration with cross-functional teams, including clinical research, regulatory affairs, and data management.
Key Responsibilities:
- Oversee the planning, execution, and completion of clinical trials.
- Develop and manage study timelines, budgets, and resource allocation.
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and international guidelines.
- Coordinate with internal and external stakeholders, including CROs, vendors, and clinical sites.
- Prepare and review study-related documents, including protocols, informed consent forms, and case report forms.
- Conduct site selection, initiation, monitoring, and close-out visits.
- Monitor trial progress and address any issues that arise.
- Provide leadership and mentorship to junior team members.
- Report on study status to senior management and other stakeholders.
- Assist in the preparation of regulatory submissions and responses to regulatory agencies.
- Ensure high quality data collection and management.
Qualifications:
- Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical trial management in the biotech or pharmaceutical industry.
- Experience with rare disease clinical trials.
- Strong knowledge of clinical trial design, implementation, and regulatory requirements.
- Proven experience managing complex clinical trials, including Phase I-III studies.
- Excellent organizational and project management skills.
- Ability to work effectively in a fast-paced, team-oriented environment.
- Strong communication and interpersonal skills.
- Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel as needed.
What They Offer:
- Competitive salary and benefits package.
- Opportunity to work on cutting-edge therapies in a collaborative environment.
- Professional development and career growth opportunities.
- Flexible working arrangements.
