Senior Project Manager - Clinical Operations

Key Responsibilities

• Lead end-to-end project management for clinical BPO programs including planning, execution, monitoring, and closure.
• Develop and manage project plans, timelines, budgets, and resource allocation.
• Serve as the primary client liaison, ensuring transparent communication and proactive issue resolution.
• Oversee cross-functional teams including clinical operations, data management, pharmacovigilance, and regulatory support.
• Ensure compliance with GxP, FDA, ICH, and other applicable regulatory requirements.
• Identify risks and implement mitigation strategies to ensure project success.
• Track project performance metrics and provide regular status reports to stakeholders.
• Drive continuous improvement initiatives and process optimization within the BPO environment.
• Support business development activities including proposals, bids, and client presentations.
• Mentor and coach junior project managers and team members.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Business, or related field; advanced degree preferred.
• 8–12+ years of experience in clinical research, outsourcing, or healthcare BPO environment.
• 5+ years of project management experience managing complex, multi-functional projects.
• Strong knowledge of clinical trial processes and regulatory requirements.
• Proven experience managing global or multi-regional projects.
• Preferred Certifications: Project Management Professional (PMP) or equivalent (e.g., PRINCE2 Practitioner), Good Clinical Practice (GCP) Certification, ICH-GCP training certification (current and up to date), Clinical research compliance training (e.g., FDA, EMA regulatory training), Lean Six Sigma Green Belt or higher (preferred in BPO operational environments).

Skills & Competencies

• Exceptional leadership and stakeholder management skills.
• Strong communication and client-facing abilities.
• Financial acumen including budgeting and forecasting.
• Risk management and problem-solving expertise.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in project management tools (e.g., MS Project, Smartsheet).