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

📌 Ba/be Manager Bengaluru
🏢 Elite Biopharma
📍 Bengaluru