Responsible for providing leadership, governance, industry expertise and best practices to our clients, client projects and the teams dedicated to serving them. Responsible for staff management and directing and managing services for client projects to assure high quality, on-time, and on-budget services while promoting excellent customer service.
What You'll Be Doing
- Provide leadership and oversight for global clinical study management and project delivery, ensuring projects remain 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 while 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 project milestones.
- Serve as Project Manager for assigned studies when required, including oversight of start-up, execution, and closeout activities 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 procedures related to project management and therapeutic team operations to ensure quality and regulatory compliance.
- Perform additional duties, assignments, and special projects as required.
What We Look For- 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.
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
