Bachelor's degree in Life Sciences, Clinical Research, Healthcare, Data Management, Business, or related field
Advanced degree (MD, Master's, or equivalent) preferred; expertise in oncology and/or radiology favored
8+ years of clinical trials experience in a CRO or pharmaceutical setting
5+ years of leadership and project management experience
Experience managing teams and global projects in regulated environments
Strong knowledge of project management, clinical research, imaging operations, and data management processes
Responsibilities
Lead development and improvement of business requirements documentation and operational processes
Identify and implement process enhancements for efficiency and quality
Collaborate with Medical Affairs, Product Development, and Data Management teams
Align system enhancements with organizational objectives
Support user acceptance testing, training, and client demonstrations
Evaluate emerging imaging technologies and methodologies
Manage strategic client relationships and governance activities
Conduct study audits and assess operational resource needs
Benefits
Medical, dental, and vision coverage
Paid time off
Employee assistance and wellness programs
Life and disability insurance
Full Job Description
What We Offer
Competitive compensation
Medical, dental, and vision coverage
Paid time off
Employee assistance and wellness programs
Life and disability insurance
What You'll Be Doing
Lead the development, delivery, and continuous improvement of business requirements documentation and operational processes within the therapeutic area.
Identify and implement process improvements to enhance efficiency, quality, and execution timelines across imaging and Medical Affairs functions.
Partner with Medical Affairs, Product Development, Validation Services, and Data Management teams to strengthen collaboration, knowledge sharing, and operational effectiveness.
Align system enhancements and business process improvements with organizational objectives and long-term growth strategies.
Serve as a subject matter expert supporting user acceptance testing, end-user training, and client demonstrations.
Evaluate emerging imaging technologies, methodologies, and operational practices to improve service delivery and scientific excellence.
Support the development of white papers, manuscripts, presentations, imaging manuals, study charters, and study-specific documentation.
Lead the interpretation and implementation of operational strategies related to new imaging criteria and clinical trial requirements.
Engage directly with clients by providing expertise on clinical protocols, study charters, governance activities, and data queries.
Monitor operational performance metrics and implement continuous improvement initiatives across the department.
Establish and maintain standardized processes, best practices, and quality standards across therapeutic areas and drug platforms.
Conduct study audits and assess resource requirements to ensure consistent execution and operational excellence.
Manage workload forecasting, resource planning, and staffing strategies to support global project delivery.
Oversee strategic client relationships through governance meetings and ongoing collaboration.
Lead, mentor, develop, and evaluate team members while fostering a collaborative and high-performing culture.
Communicate performance expectations, conduct performance reviews, support employee development, and drive succession planning.
Participate in recruiting activities, including interviewing, hiring recommendations, onboarding, and training.
Support business development efforts through proposal reviews, client meetings, bid defense presentations, and strategic consultation.
Ensure compliance with company policies, quality standards, regulatory requirements, and Standard Operating Procedures (SOPs).
Contribute to departmental and organizational success through ongoing process improvement and cross-functional collaboration.
What We Look For
Bachelor's degree in Life Sciences, Clinical Research, Healthcare, Data Management, Business, or a related field.
Advanced degree (MD, Master's degree, or equivalent) with oncology and/or radiology expertise preferred.
8+ years of clinical trials experience within a CRO or pharmaceutical research organization.
5+ years of leadership and project management experience.
Experience managing teams, resources, and complex global projects.
Experience working within regulated environments, including GCP, GLP, ISO standards, and 21 CFR Part 11 requirements.
Strong knowledge of clinical research, imaging operations, project management, and data management processes.
Experience with project planning, forecasting, resource management, and financial oversight.
Working knowledge of ICH guidelines and FDA regulations.
Demonstrated ability to build collaborative relationships with internal stakeholders and external clients.
Strong organizational, communication, presentation, and time management skills.
Experience using Microsoft Office applications, including Word and Excel.
Proven ability to lead teams, drive change, and deliver results in a fast-paced environment.
