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Title
Text copied to clipboard!Clinical Trial Director
Description
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We are looking for a highly skilled and experienced Clinical Trial Director to lead and manage our clinical trials. The ideal candidate will have a strong background in clinical research, project management, and regulatory compliance. As a Clinical Trial Director, you will be responsible for overseeing all aspects of clinical trials, including planning, execution, and reporting. You will work closely with cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs, to ensure that trials are conducted in accordance with regulatory requirements and company standards. You will also be responsible for developing and maintaining relationships with key stakeholders, including investigators, study coordinators, and regulatory agencies. The successful candidate will have excellent leadership and communication skills, as well as the ability to manage multiple projects simultaneously. You will be expected to stay current with industry trends and best practices, and to continuously improve the efficiency and effectiveness of our clinical trial processes. This is a critical role that requires a high level of expertise and dedication, and offers the opportunity to make a significant impact on the development of new therapies and treatments.
Responsibilities
Text copied to clipboard!- Oversee the planning, execution, and reporting of clinical trials.
- Ensure compliance with regulatory requirements and company standards.
- Develop and maintain relationships with key stakeholders.
- Manage cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs.
- Monitor trial progress and address any issues that arise.
- Develop and implement trial protocols and standard operating procedures.
- Ensure the accuracy and integrity of trial data.
- Prepare and submit regulatory documents and reports.
- Manage trial budgets and timelines.
- Provide leadership and guidance to clinical trial staff.
- Stay current with industry trends and best practices.
- Continuously improve trial processes and procedures.
- Ensure patient safety and ethical conduct of trials.
- Coordinate with external vendors and service providers.
- Conduct site visits and audits as needed.
- Develop and deliver training programs for trial staff.
- Participate in the selection and qualification of trial sites.
- Review and approve trial-related documents and materials.
- Communicate trial progress and results to senior management.
- Ensure proper documentation and record-keeping for all trial activities.
Requirements
Text copied to clipboard!- Bachelor's degree in a related field; advanced degree preferred.
- Minimum of 10 years of experience in clinical research.
- Strong knowledge of regulatory requirements and guidelines.
- Excellent project management skills.
- Proven leadership and team management abilities.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to manage multiple projects simultaneously.
- Experience with clinical trial management systems.
- Knowledge of Good Clinical Practice (GCP) guidelines.
- Experience in developing and implementing trial protocols.
- Ability to work effectively with cross-functional teams.
- Strong attention to detail and accuracy.
- Ability to travel as needed.
- Experience with budget management and financial reporting.
- Strong organizational and time management skills.
- Ability to work under pressure and meet deadlines.
- Experience with regulatory submissions and reporting.
- Knowledge of data management and biostatistics.
- Commitment to patient safety and ethical conduct of trials.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with managing clinical trials?
- How do you ensure compliance with regulatory requirements?
- What strategies do you use to manage multiple projects simultaneously?
- Can you provide an example of a challenging trial you managed and how you addressed the challenges?
- How do you develop and maintain relationships with key stakeholders?
- What is your approach to ensuring the accuracy and integrity of trial data?
- How do you stay current with industry trends and best practices?
- Can you describe your experience with budget management and financial reporting?
- How do you handle conflicts or issues that arise during a trial?
- What is your experience with clinical trial management systems?
