Job Title: Clinical Study Consultant
Job Description:
We are seeking a dedicated and experienced Clinical Study Consultant to join our dynamic team. The Clinical Study Consultant will play a pivotal role in managing and overseeing clinical studies from initiation to completion. This position is designed for a professional with a strong background in clinical research who can provide expert guidance and strategic advice throughout the clinical study lifecycle.
As a Clinical Study Consultant, you will be responsible for designing, planning, and executing clinical study protocols in accordance with regulatory requirements and organizational standards. Your role will involve collaborating with cross-functional teams, including clinical researchers, project managers, and regulatory affairs specialists, to ensure the successful execution of clinical studies.
Key responsibilities:
• Clinical Study Design: Develop and review clinical study protocols, ensuring that they meet scientific, regulatory, and ethical standards. The Clinical Study Consultant will work closely with stakeholders to refine study objectives and methodologies.
• Study Management: Oversee the day-to-day operations of clinical studies, including site selection, investigator recruitment, and patient enrollment. The Clinical Study Consultant will ensure that studies are conducted according to the protocol and within the agreed timelines.
• Regulatory Compliance: Ensure that all clinical studies comply with relevant regulations, guidelines, and best practices. The Clinical Study Consultant will prepare and submit regulatory documents and manage interactions with regulatory authorities.
• Data Analysis and Reporting: Review and interpret clinical study data, providing insights and recommendations based on the findings. The Clinical Study Consultant will prepare detailed study reports and presentations for internal and external stakeholders.
• Risk Management: Identify and mitigate potential risks associated with clinical studies. The Clinical Study Consultant will develop contingency plans and address any issues that arise during the study.
• Collaboration and Communication: Facilitate effective communication between all parties involved in the clinical study. The Clinical Study Consultant will coordinate meetings, prepare documentation, and ensure that all team members are informed of study progress and changes.
Requirements:
• Bachelor's degree in Life Sciences, Medicine, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in clinical research, with a proven track record in clinical study management.
• In-depth knowledge of clinical study regulations, guidelines, and best practices.
• Strong analytical skills with the ability to interpret complex clinical data.
• Excellent organizational and project management skills.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Proficiency in clinical trial management software and data analysis tools.
• Ability to handle multiple studies simultaneously and manage competing priorities.
Benefits:
• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Professional development opportunities and continuing education support.
• Flexible work arrangements and generous paid time off.
• A collaborative and supportive work environment with opportunities for career advancement.
Qualifications:
• Extensive experience in clinical study design and management.
• Expertise in regulatory compliance and clinical trial processes.
• Proven ability to analyze and interpret clinical data.
• Strong problem-solving and decision-making skills.
• Demonstrated success in managing cross-functional teams and projects.
• Knowledge of industry standards and best practices in clinical research.
Location: Gardner, KS
Posted: Sept. 18, 2024, 9:52 a.m.
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