Project Leader - Analytical

Job Description

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. Key Responsibilities: 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.