Scientific > Clinical Trial Director
Salary National Average
| Low | Medium | High |
|---|---|---|
| 135580.0000 | 154710.0000 | 194720.0000 |
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Candidate Supply: 273 Job Openings: 97
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Short Description:
A Clinical Trial Director oversees the design, execution, and management of clinical trials, ensuring they meet regulatory standards, ethical guidelines, and company objectives. Their duties include developing trial protocols, managing budgets, overseeing trial timelines, and coordinating with cross-functional teams, including clinical researchers, regulatory bodies, and sponsors. The Clinical Trial Director ensures that studies are conducted efficiently, ethically, and within scope, addressing any issues that arise during the trial process. Strong leadership, strategic planning, and in-depth knowledge of clinical research regulations are essential for success in this role, as the Clinical Trial Director plays a critical role in guiding trials from inception to completion.
Duties / Responsibilities:
- Design and validate clinical databases, including designing or testing logic checks.
- Process clinical data, including receipt, entry, verification, or filing of information.
- Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
- Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and workflow processes
- Monitor work productivity or quality to ensure compliance with standard operating procedures.
- Prepare appropriate formatting to data sets as requested.
- Design forms for receiving, processing, or tracking data.
- Prepare data analysis listings and activity, performance, or progress reports.
- Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.
- Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
Skills / Requirements / Qualifications
- Education: Advanced degree in life sciences, clinical research, or a related field (e.g., MD, PhD, PharmD, or Master’s in Clinical Research) is typically required.
- Experience in Clinical Trial Management: 8+ years of experience in clinical trial management, with a proven track record of overseeing multiple trials across various phases (Phase I-IV).
- Leadership and Team Management Skills: Strong leadership abilities with experience managing cross-functional teams, including clinical research associates, coordinators, and data managers.
- In-Depth Knowledge of Regulatory Guidelines: Thorough understanding of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and local/international regulations governing clinical trials.
- Strategic Planning and Organizational Skills: Ability to develop, implement, and manage clinical trial strategies and timelines while ensuring adherence to budget and operational goals.
- Excellent Communication Skills: Strong verbal and written communication skills for interacting with internal stakeholders, sponsors, regulatory agencies, and clinical site teams.
- Problem-Solving and Decision-Making Skills: Critical thinking and analytical abilities to identify issues, mitigate risks, and make informed decisions throughout the trial lifecycle.
- Proficiency with Clinical Trial Systems: Expertise in using clinical trial management systems (CTMS), electronic data capture (EDC) systems, and project management software.
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