Manager, Project Management

Apotex; Bengaluru; Presencial; INR 3.500.000 - 6.000.000; Jornada completa

Descripción de la vacante

Apotex in Bengaluru seeks an experienced project leader to oversee BE, Patient PK, POC and 505(b)(2) CRO-driven studies from feasibility to final report. You will own planning, CRO oversight, regulatory coordination, risk management, budgets, and milestone delivery.

The role requires a minimum of 15 years in clinical study leadership, advanced degrees (M.Pharm/MSc/MBA), and strong cross-functional collaboration with Regulatory Affairs, Clinical Operations, QA and Sponsors.

Formación

• Advanced proficiency in bioequivalence studies and program leadership.
• Experience managing BE, patient PK, POC and 505(b)(2) CRO-outsourced studies.
• Ability to coordinate regulatory submissions, ethics approvals, and inspection readiness.
• Strong cross-functional collaboration with Clinical Operations, Regulatory Affairs, QA, and Sponsors.
• Experience tracking budgets, timelines, risk registers, and KPIs.

Responsabilidades

• 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.

Conocimientos

Bioequivalence studies

Project Management

Patient PK Studies

POC 505(b)(2) Programs

CRO Vendor Oversight

Risk Budget Management

Communication

Change Management

Drive for Results

Planning & Prioritizing

Leadership

Decision Making

Educación

M.Pharm.

MSc.

MBA

Descripción del empleo

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

Project Leadership

• 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.

Clinical Study Management

• 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.

CRO Vendor Management

• 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.

Regulatory Compliance

• Coordinate regulatory submissions, ethics approvals, and inspection readiness.
• Ensure compliance with GCP, SOPs, protocol requirements, and applicable global regulations.

Cross-functional Coordination

• Collaborate with Clinical Operations, Bioanalytical, Regulatory Affairs, Data Management, Medical Writing, QA, Supply Chain, and Sponsors.
• Facilitate effective communication and alignment among all stakeholders.

Governance Reporting

• 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.

Knowledge, Skills and Abilities

• 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

Experience

• Minimum 15 years of experience