Overview
Lead the delivery of global clinical research projects, providing leadership, governance and operational oversight for studies and the teams that run them.
What you'll do
- Provide leadership and oversight for global clinical study management and project delivery, keeping projects on schedule, within budget and aligned with contractual obligations.
- Evaluate study progress, resource allocation and team workload, implementing adjustments and mitigation strategies as needed.
- Proactively identify, assess and mitigate risks across assigned programs and studies.
- Manage escalations and resolve operational, client and project challenges, maintaining issue tracking and documentation.
- Support Clinical Project Managers in client communications regarding study status, risks, timelines and deliverables.
- Lead cross-functional collaboration with internal and external stakeholders to ensure successful project execution and study completion.
- Coordinate and facilitate routine status meetings to monitor study progress, resource utilization and key milestones.
- Serve as Project Manager for assigned studies when required, including oversight of start-up, execution and closeout for complex, high-profile customer programs.
- Guide study teams to maintain consistency across Therapeutic Areas and programs, promoting operational efficiency and alignment with customer objectives.
- Partner with senior leadership to prioritize deliverables, address resource needs and communicate critical project updates.
- Influence strategic decision-making and drive operational excellence through continuous process improvement initiatives.
- Identify opportunities to improve workflows, tools, procedures and service delivery within therapeutic or imaging teams.
- 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 improve study delivery, quality and efficiency.
- Coach, mentor and develop Project Management team members through performance management, career development and ongoing feedback.
- Support onboarding and training of new team members while ensuring compliance with required training completion and documentation.
- Manage team assignments and workload distribution to encourage growth, accountability and high performance.
- Establish, maintain and enforce departmental standards, SOP compliance and study management best practices.
- Review and update project management and therapeutic team procedures to ensure quality and regulatory compliance.
- Perform additional duties, assignments and special projects as required.
What you'll need
- Bachelor's degree in Life Sciences, Pharmacy, Nursing or a related discipline.
- 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.
- 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 communicate effectively 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 to changing business needs.
- Valid passport and ability to travel up to 20% as needed.
Nice to have
- Master's degree.
- Medical Imaging experience.
Details
- Work mode: Remote, United States.
- Travel of up to 20% as needed.
Read the full description and apply on the company’s own careers page.