Bioanalytical Project Manager

Summary

Responsible for end-to-end oversight of bioanalytical components in bioequivalence clinical studies, project management, CRO liaison activities, analytical monitoring, and reviewing study reports, ensuring quality and timely delivery in accordance with current guidelines and company standards.

Key Responsibilities

• monitor bioanalytical study progress with respect to milestones, budgets, and timelines, providing regular status updates to stakeholders.
• Coordinate and track bioanalytical data flow; oversee CRO activities during study execution to ensure protocol adherence and GCP/GLP compliance.
• Serve as the primary point of contact for sponsor interactions; organize and lead study review meetings, maintain action logs, and resolve sponsor queries in a timely manner.
• Review protocols, analysis plans, amendments, and related documents to ensure scientific accuracy and regulatory compliance (GxP, ICH, EMA/FDA requirements).
• Draft, review, and finalize regulatory submission documents, including interim and final study reports, narratives, and responses to regulatory comments.
• Conduct/document monitoring visits or remote oversight of analytical phases, tracking deviations, and implementing corrective actions.
• Ensure rigorous data integrity, document archiving, and compliance with all study and reporting SOPs.
• Proactively identify project risks, scope changes, or technical issues and execute risk mitigation or escalation as needed.

Requirements

• M.Pharm, M.Sc, or higher degree in Pharmaceutical Sciences, Bioanalytical Chemistry, or related field.
• 710 years of hands-on experience in bioequivalence studies (CRO or sponsor side) with demonstrable exposure to project management, monitoring, and report writing.
• In-depth knowledge of GCP, GLP, and regulatory guidelines relevant to BE studies(ICH, EMA, FDA).
• Proficiency with bioanalytical software (e.g., Watson LIMS) and electronic documentation systems.
• Strong skills in technical writing, regulatory correspondence, and scientific communication.
• Experienced in clinical study data review, protocol compliance, and site/CRO management.
• Excellent organizational, critical thinking, and interpersonal abilities.

Preferred Skills

• Experience supervising or mentoring junior staff.
• Ability to manage multiple concurrent projects in a cross-functional, multicultural environment.
• Problem-solving mindset and demonstrated effectiveness in resolving data, compliance, or operational issues.
• Strong familiarity with electronic Trial Master Files (eTMF), eCRF, and best practices in study documentation.