Explore the critical requirements, core duties, primary responsibilities, and key skills that should be included in a comprehensive Clinical Trial Manager job description.
What does a Clinical Trial Manager do?
A clinical trial manager is responsible for overseeing and managing clinical trials, as well as supervising clinical research associates (CRA) and clinical data managers (CDM). They report to a clinical project manager (CPM).
Job Description
We are seeking an organized clinical trial manager to lead and monitor projects, ensuring high-quality trials. The manager works closely with the clinical project manager to review budgets, make necessary changes, and plan projects with the client and clinical monitoring team. They also visit clinical trial investigators, provide necessary supplies, and oversee expenses and timesheets for CRAs. Additionally, the manager collects and reviews case report forms and collaborates with investigators to write final reports.
To succeed in this role, candidates must meet the client's goals within budget and on time. The ideal candidate is skilled at multitasking, prioritizing tasks, and delivering exceptional client service.
Job Duties and Responsibilities
- Collaborate with the project manager to set goals for clinical monitoring staff and ensure compliance with project objectives.
- Create and implement study-specific clinical monitoring tools and documents.
- Develop and manage the trial budget.
- Identify, select, and manage trial sites and coordinate site management activities.
- Supervise the clinical monitoring team.
- Provide project-specific training to clinical research associates and hold regular meetings with them.
- Document and communicate interactions with clients, acting as their representative.
- Arrange and conduct site visits.
- Collect and review trial documents.
- Ensure compliance with standard operating procedures (SOPs) and local regulations, as well as CFR, ICH, and GCP guidelines.
Requirements and Qualifications
- Bachelor's degree in nursing or life sciences.
- At least 3 years of experience in a pharmaceutical company or related field.
- Strong understanding of marketing and statistics.
- Excellent communication skills, both written and verbal.
- Proficient in Microsoft Office Word and Excel.
- Ability to work independently and prioritize tasks.
- Familiarity with Electronic Data Capture (EDC) systems.
- Willingness to travel.
- Valid driver's license.
Clinical Trial Manager Salary
The earning potential of a Clinical Trial Manager can vary significantly based on factors such as geographic location, industry, professional experience, educational background, and the specific employer. On average, the annual salary for an Clinical Trial Manager in the United States is approximately $114994.