The CTM supports the local trial team to ensure patient safety, data integrity, and compliance with Good Clinical Practice (GCP) and regulatory requirements. This includes coordinating trial activities, managing cross-functional teams, and working with investigators, clinical research associates (CRAs), study sites, and external vendors throughout trial preparation, execution, and closeout.
Key Responsibilities
- Support and coordinate the local clinical trial team.
- Oversee trial preparation, execution, and closeout activities.
- Work closely with Site Monitoring Leads and CRAs to ensure proper trial oversight.
- Serve as the primary point of contact for CRAs, investigators, and site staff.
- Monitor recruitment goals, timelines, budgets, and quality standards.
- Ensure compliance with GCP, patient safety requirements, and regulatory guidelines.
- Identify potential risks, resolve issues, and develop mitigation plans.
- Coordinate activities across multiple studies and therapeutic areas.
- Manage relationships with internal teams, external stakeholders, and clinical research sites.
- Participate in process improvement initiatives and the implementation of innovative clinical trial methods.
- Travel domestically approximately 10–20% of the time.
Required Qualifications and Experience
- Experience managing clinical trials within a complex regulatory environment.
- Experience working with global clinical trials and cross-functional teams.
- Experience in inflammation-related clinical trials is preferred, particularly dermatology studies.
- Strong communication, leadership, project management, and stakeholder management skills.
- Knowledge of clinical trial operations, scientific processes, and regulatory requirements.
- Ability to manage multiple studies, competing priorities, and complex project timelines.
- Strong problem-solving skills with the ability to identify risks and resolve conflicts.
- Ability to coordinate resources and influence teams across different organizational levels.
- Willingness and ability to travel domestically 10–20%.
Education and Experience Requirements
Candidates must meet one of the following:
- Bachelor's degree with at least 6 years of clinical research experience.
- Master's degree or PharmD with at least 4 years of clinical research experience.
- PhD or MD with at least 2 years of clinical research experience.
Pharmaceutical industry experience is preferred.