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Title
Text copied to clipboard!Clinical Research Director
Description
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We are looking for a highly skilled and experienced Clinical Research Director to lead and oversee our clinical research projects and teams. The ideal candidate will have a strong background in clinical research, project management, and team leadership. As the Clinical Research Director, you will be responsible for ensuring the successful planning, execution, and completion of clinical trials and studies. You will work closely with cross-functional teams, including clinical operations, regulatory affairs, data management, and biostatistics, to ensure that all research activities are conducted in compliance with regulatory requirements and industry standards. Your role will also involve developing and implementing research strategies, managing budgets, and ensuring that all projects are completed on time and within scope. Additionally, you will be responsible for mentoring and developing junior staff, fostering a collaborative and innovative research environment, and maintaining strong relationships with key stakeholders, including sponsors, investigators, and regulatory agencies. The successful candidate will have excellent communication and organizational skills, a keen attention to detail, and a passion for advancing medical knowledge and improving patient outcomes.
Responsibilities
Text copied to clipboard!- Lead and oversee clinical research projects and teams.
- Develop and implement research strategies and protocols.
- Ensure compliance with regulatory requirements and industry standards.
- Manage project budgets and timelines.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, data management, and biostatistics.
- Mentor and develop junior staff.
- Foster a collaborative and innovative research environment.
- Maintain strong relationships with key stakeholders, including sponsors, investigators, and regulatory agencies.
- Ensure the successful planning, execution, and completion of clinical trials and studies.
- Monitor and report on project progress and performance.
- Identify and mitigate risks associated with clinical research projects.
- Ensure the accuracy and integrity of clinical data.
- Develop and maintain standard operating procedures (SOPs) for clinical research activities.
- Provide scientific and technical guidance to research teams.
- Stay current with industry trends and advancements in clinical research.
- Prepare and present research findings to internal and external stakeholders.
- Ensure the ethical conduct of clinical research.
- Coordinate and oversee site selection and management.
- Review and approve study-related documents, including protocols, informed consent forms, and case report forms.
- Participate in the development and submission of regulatory documents.
Requirements
Text copied to clipboard!- Advanced degree in a relevant field (e.g., MD, PhD, PharmD).
- Minimum of 10 years of experience in clinical research.
- Proven track record of leading and managing clinical research projects.
- Strong knowledge of regulatory requirements and industry standards.
- Excellent project management and organizational skills.
- Strong leadership and team management abilities.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a cross-functional team environment.
- Strong analytical and problem-solving skills.
- Attention to detail and a commitment to quality.
- Experience with budget management and financial oversight.
- Ability to mentor and develop junior staff.
- Strong understanding of clinical trial design and methodology.
- Experience with data management and biostatistics.
- Ability to manage multiple projects and priorities simultaneously.
- Proficiency in Microsoft Office and clinical trial management software.
- Strong ethical standards and a commitment to patient safety.
- Ability to travel as needed.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Strong scientific and technical writing skills.
Potential interview questions
Text copied to clipboard!- Can you describe your experience leading and managing clinical research projects?
- How do you ensure compliance with regulatory requirements and industry standards?
- Can you provide an example of a challenging clinical research project you managed and how you overcame the challenges?
- How do you foster a collaborative and innovative research environment?
- What strategies do you use to mentor and develop junior staff?
- How do you manage project budgets and timelines?
- Can you describe your experience with data management and biostatistics?
- How do you ensure the accuracy and integrity of clinical data?
- What is your approach to risk management in clinical research projects?
- How do you stay current with industry trends and advancements in clinical research?
- Can you describe your experience with regulatory submissions and interactions with regulatory agencies?
- How do you handle conflicts or disagreements within your research team?
- What is your experience with site selection and management?
- How do you ensure the ethical conduct of clinical research?
- Can you provide an example of a successful research strategy you developed and implemented?
- How do you prepare and present research findings to stakeholders?
- What is your experience with standard operating procedures (SOPs) for clinical research activities?
- How do you balance multiple projects and priorities simultaneously?
- Can you describe your experience with clinical trial management software?
- What motivates you to work in clinical research?