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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical study management, project delivery, and operational excellence within clinical development environments. Proficient in leading cross-functional teams, managing resources, and ensuring compliance with regulatory standards.
Highest-signal resume keywords
Clinical Research ExperienceProject Management MethodologiesGood Clinical Practice (GCP)Leadership in Clinical DevelopmentMicrosoft Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ProcessesDrug Development PracticesRisk Assessment and MitigationOperational ReadinessStudy Management Best Practices
Soft Skills
Coaching and MentoringOrganizational SkillsProblem-Solving SkillsDecision-Making SkillsEffective Communication
Tools & Technologies
Project Management ToolsMicrosoft Office Applications
Industry Keywords
Clinical OperationsClinical Trial ManagementCROPharmaceuticalBiotechnologyInternational Council for Harmonisation (ICH) GuidelinesFDA RegulationsMedical Imaging
About the role
Key responsibilities & impact- 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, including 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 improve 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
What you’ll need- 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
