Project Management Clinical Research & Bioequivalence Studies

We are looking for an experienced Project Management professional with 7 to 8 years of relevant experience in Bioanalytical Studies, Bioequivalence (BE) Studies, and Clinical Trial Phases. The ideal candidate should have prior experience working with a Clinical Research Organization (CRO) and hands-on exposure to the monitoring of bioequivalence studies and clinical trials.

Key Responsibilities

• Plan, coordinate, and monitor bioanalytical studies, bioequivalence studies, and clinical trial activities.
• Manage project timelines, deliverables, resources and study milestones.
• Participate in the monitoring of bioequivalence studies and clinical trials to ensure compliance with approved protocols, SOPs, and applicable regulatory requirements.
• Coordinate with clinical operations, bioanalytical laboratories, medical teams, sponsors, and other stakeholders.
• Track study progress, identify project risks, resolve operational challenges, and ensure timely completion of deliverables.
• Ensure adherence to applicable GCP, GLP, ethical standards, and regulatory guidelines as relevant to the studies.
• Maintain accurate study documentation, progress reports, and project-related records.
• Support audits, inspections and quality compliance activities related to clinical and bioequivalence studies.

Required Qualifications & Experience

• 7 - 8 years of relevant experience in clinical research, project management or study coordination within a Clinical Research Organization (CRO).
• Practical experience in bioanalytical and bioequivalence studies and clinical trial phases.
• Demonstrated participation in the monitoring of bioequivalence studies and clinical trials.
• Strong understanding of clinical study protocols, GCP principles, study documentation and regulatory compliance.
• Excellent project coordination, stakeholder management, communication, and problem-solving skills.
• Ability to manage multiple projects and meet defined timelines and quality standards.

Preferred Candidate Profile

Candidates with hands-on CRO experience, strong project execution capabilities, and practical exposure to the monitoring of clinical trials and bioequivalence studies will be preferred.