Senior Project Manager - Clinical Operations

Role Description

The Senior Project Manager (SPM) is responsible for leading and delivering complex clinical business process outsourcing (BPO) projects across multiple clients and therapeutic areas. This role ensures projects are executed on time, within scope, and within budget while maintaining high-quality standards and regulatory compliance. The SPM serves as the primary point of contact for clients and internal stakeholders, driving operational excellence and client satisfaction.

• 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.

Requirements

• 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).

Work Environment

This role operates in a dynamic, client-driven clinical BPO environment, requiring collaboration across global teams and flexibility to accommodate different time zones.

Reporting Structure

Reports to: Senior Vice President of Clinical Operations

Location

View email address on remotive.com USA, United States of America