Project Leader - Analytical

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We are seeking an experienced Clinical Research Project Leader to oversee bioanalytical projects within our clinical research division. The ideal candidate will have 8-15 years of experience in analytical methods and bioanalytical research, demonstrating a strong understanding of regulatory requirements and industry best practices.

• Project Management: Lead bioanalytical projects from initiation to completion, ensuring adherence to timelines, budgets, and quality standards. Develop project plans, manage resources, and coordinate cross-functional teams.
• Analytical Expertise: Utilize extensive knowledge of analytical techniques (such as LC-MS/MS, HPLC, and others) to guide bioanalytical method development, validation, and sample analysis. Ensure compliance with relevant regulatory standards (FDA, EMA, ICH).
• Collaboration: Work closely with clinical operations, regulatory affairs, and other departments to ensure seamless integration of bioanalytical activities within clinical trials. Facilitate communication between internal teams and external partners.
• Data Analysis Reporting: Oversee data analysis and interpretation of bioanalytical results. Prepare and review study reports, ensuring accuracy and compliance with regulatory requirements.
• Quality Assurance: Implement and maintain quality control processes to ensure the integrity and reliability of bioanalytical data. Participate in audits and inspections as required.
• Mentorship: Provide guidance and mentorship to junior team members, fostering a collaborative and innovative work environment.
• Continuous Improvement: Identify opportunities for process improvements in bioanalytical workflows. Stay updated on industry trends and advancements in analytical techniques.
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