Project Management Clinical Research & Bioequivalence Studies

Althera Laboratories India Pvt Ltd, Bangalore; Bommasandra; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Althera Laboratories India Pvt Ltd, Bangalore seeks an experienced Project Management professional with 7–8 years in bioanalytical studies, BE studies, and clinical trials. Prior CRO exposure and hands-on BE/clinical monitoring are essential.

Responsibilities include planning, coordinating, and tracking study progress, timelines, resources, and milestones while ensuring GCP/GLP compliance and quality documentation. Audits and inspections support will be required.

Qualifications

• 7–8 years in clinical research or study coordination within a CRO.
• Hands-on monitoring of bioequivalence (BE) studies and clinical trials.
• Experience with CRO environments and study execution.
• Strong understanding of GCP, GLP, and regulatory requirements.
• Excellent project coordination and communication skills.
• Ability to manage multiple projects and meet timelines and quality standards.

Responsibilities

• Plan, coordinate, and monitor bioanalytical studies, BE studies, and clinical trial activities.
• Manage project timelines, deliverables, resources and study milestones.
• Monitor compliance with approved protocols, SOPs, and regulatory guidelines.
• Coordinate with clinical operations, bioanalytical labs, medical teams, sponsors, and stakeholders.
• Track study progress, identify risks, resolve operational challenges, ensure timely deliverables.
• Support audits, inspections and quality compliance activities related to studies.

Skills

Project management

Clinical research

Bioanalysis & BE studies

GCP/GLP compliance

Regulatory compliance

Stakeholder management

Monitoring of clinical trials

Job description

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.