Senior Lead, Clinical Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership and oversight for global clinical study management and project delivery.

• Evaluate study progress, resource allocation, and team workload, implementing adjustments and mitigation strategies.

• Identify, assess, and mitigate risks across assigned programs and studies.

• Manage escalations and resolve operational, client, and project challenges.

• Support Clinical Project Managers in client communications regarding study status, risks, timelines, and deliverables.

• Lead cross-functional collaboration with internal and external stakeholders.

• Coordinate and facilitate routine status meetings.

• Serve as Project Manager for assigned studies, encompassing start-up, execution, and closeout activities.

• Guide study teams across Therapeutic Areas and programs.

• Partner with senior leadership to prioritize deliverables, address resource needs, and communicate critical project updates.

• Drive operational excellence through continuous process improvement initiatives.

• Lead departmental initiatives, including planning, execution, communication, training, and progress reporting.

• Serve as a Therapeutic Area and/or Imaging Lead for operational readiness and implementation of new processes and procedures.

• Monitor operational challenges and recommend solutions to enhance study delivery, quality, and efficiency.

• Coach, mentor, and develop Project Management team members.

• Support onboarding and training of new team members.

• Manage team assignments and workload distribution.

• Establish, maintain, and enforce departmental standards, SOP compliance, and study management best practices.

• Review and update project management and therapeutic team procedures.

• Perform additional duties, assignments, and special projects as required.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related discipline required; Master's degree preferred.

• 5-10 years of clinical research experience within a CRO, pharmaceutical, biotechnology, or related clinical development environment, including significant project management responsibility.

• Previous people management and leadership experience within clinical development, clinical operations, or clinical trial management.

• Strong knowledge of clinical trial processes, project management methodologies, and drug development practices.

• Working knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and FDA regulations.

• Experience supporting global clinical studies and leading cross-functional, geographically dispersed teams.

• Medical Imaging experience preferred.

• Demonstrated ability to coach, mentor, and develop team members.

• Strong organizational, prioritization, problem-solving, and decision-making skills.

• Excellent verbal and written communication skills, including the ability to effectively communicate in English with internal and external stakeholders.

• Proficiency with Microsoft Office applications and project management tools.

• Detail-oriented with the ability to manage multiple priorities and adapt effectively to changing business needs.

• Valid passport and ability to travel up to 20% as needed.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.