Job Summary

Lead and manage end-to-end execution of Bioequivalence (BE), Patient PK, POC, 505(b)(2), and CRO-outsourced clinical studies. Responsible for project planning, stakeholder management, CRO oversight, regulatory coordination, risk mitigation, budget control, and timely delivery of study milestones from feasibility through final report and archival

Job Responsibilities
Serve as the single point of accountability for assigned studies and clinical programs.
Develop project plans, timelines, resource allocation, budgets, and risk mitigation strategies.
Drive on-time delivery of project milestones, reports, and study closures.
Oversee execution of BE, Patient PK, POC, and 505(b)(2) studies.
Ensure study objectives are achieved while maintaining quality, compliance, and timeline commitments.
Monitor critical path activities and proactively resolve operational issues.
Identify, qualify, and manage CROs, laboratories, and vendors.
Track CRO performance, study deliverables, budgets, and compliance metrics.
Escalate and resolve project risks impacting scope, quality, cost, or timelines.
Coordinate regulatory submissions, ethics approvals, and inspection readiness.
Ensure compliance with GCP, SOPs,



protocol requirements, and applicable global regulations.
Collaborate with Clinical Operations, Bioanalytical, Regulatory Affairs, Data Management, Medical Writing, QA, Supply Chain, and Sponsors.
Facilitate effective communication and alignment among all stakeholders.
Maintain project dashboards, risk registers, trackers, and KPI metrics.
Provide regular project updates and management reports to leadership and sponsors.

Job Requirements
Education: Minimum M.Pharm./ MSc./ MBA.
Minimum of Advanced proficiency level in Bioequivalence studies.
Project Management
Patient PK Studies
POC 505(b)(2) Programs
CRO Vendor Oversight
Risk Budget Management
Communication Interpersonal skills
Change Management
Drive for Results
Planning Prioritizing
Leadership
Judgement Decision Making
Minimum 15 years of experience

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager, Proj Mgmt Bioequivalence Bengaluru
🏢 Apotex
📍 Bengaluru