BA/BE Manager

Role & responsibilities

• Manage BA/BE projects from feasibility to final study report.
• Review client requirements, molecules, dosage forms, strengths and reference products.
• Develop and review BA/BE study designs and protocols.
• Manage fasted, fed, single-dose, multiple-dose, crossover, replicate and parallel study designs, as applicable.
• Coordinate with clinical sites, investigators, bioanalytical laboratories, statisticians and external CRO partners.
• Manage study initiation, subject recruitment, dosing, PK sampling and study completion.
• Coordinate bioanalytical method validation and sample analysis.
• Review PK and statistical outputs, including Cmax, AUC.
• Review and coordinate preparation of clinical, bioanalytical, PK/statistical and final BA/BE reports.
• Coordinate Ethics Committee/IRB and regulatory requirements.
• Ensure compliance with applicable GCP, GLP and regulatory guidelines.
• Manage protocol deviations, CAPA, study risks and project timelines.
• Handle client communications, technical discussions and project meetings.
• Support preparation of technical proposals, feasibility assessments and quotations.
• Manage CRO/vendor selection, qualification and performance.
• Monitor project budgets, timelines and deliverables.
• Prepare BA/BE project trackers and management MIS reports.
• Lead, mentor and train BA/BE team members.
• Support regulatory submissions and responses related to BA/BE studies.

Preferred candidate profile

• BA/BE Study Management
• Bioequivalence Studies
• Clinical Research
• Pharmacokinetics
• Protocol Development
• PK/Statistical Analysis
• Bioanalytical Coordination
• CRO/Vendor Management
• Project Management
• Regulatory Compliance
• GCP
• Client Management