Manager, Proj Mgmt - Bioequivalence

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