Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or related field, or equivalent experience
Experience managing clinical research projects within a CRO or pharmaceutical environment
Clinical trial experience with the ability to manage multiple projects and timelines
Knowledge of Good Clinical Practice (GCP), ICH guidelines, and FDA regulations
Experience with project planning, budgeting, financial tracking, and resource management
Proficiency in Microsoft Office applications including Word, Excel, and Project
Knowledge of medical imaging technologies or imaging-focused clinical studies is preferred
Responsibilities
Lead study start-up activities by reviewing protocol requirements and developing project plans
Establish and maintain communication plans and reporting schedules for stakeholders
Identify project success metrics and manage risks and operational challenges
Manage project finances, including forecasting, billing, and revenue reporting
Ensure compliance with protocols, SOPs, and applicable regulations
Coordinate data collection across sites and collaborate with stakeholders
Provide leadership to project teams by setting expectations and mentoring
Support business development activities through presentations and representation at events
Oversee project closeout activities, including final deliverables and study completions
Drive continuous improvement initiatives for processes and outcomes
Benefits
Competitive compensation
Medical, dental, and vision coverage
Flexible and paid time off
Remote and hybrid work options
Tuition reimbursement
Employee assistance and wellness programs
Life and disability insurance
Full Job Description
What We Offer
Competitive compensation
Medical, dental, and vision coverage
Flexible and paid time off
Remote and hybrid work options
Tuition reimbursement
Employee assistance and wellness programs
Life and disability insurance
What You'll Be Doing
Lead study start-up activities by reviewing protocol requirements, developing project plans, defining timelines and milestones, and coordinating project documentation.
Establish and maintain project communication plans, reporting schedules, and stakeholder updates for sponsors and internal leadership.
Identify project success metrics, oversee project progress, and proactively manage risks, resources, and operational challenges.
Manage project finances, including forecasting, billing activities, scope reviews, amendments, revenue reporting, and pass-through costs.
Ensure compliance with study protocols, Standard Operating Procedures (SOPs), applicable regulations, and quality requirements.
Coordinate data collection activities across sites and collaborate with internal and external stakeholders to support successful project delivery.
Provide leadership to project teams by setting expectations, facilitating training, mentoring team members, and promoting a collaborative working environment.
Communicate protocol clarifications and revisions to project teams and ensure consistent understanding of study requirements.
Support business development activities through client presentations, capability discussions, investigator meetings, and representation at industry events.
Oversee project closeout activities, including submission support, final deliverables, and study completion activities.
Perform supervisory responsibilities as needed, including performance management, employee development, hiring support, and workforce planning.
Drive continuous improvement initiatives that enhance departmental processes, project outcomes, and customer satisfaction.
What We Look For
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related field, or equivalent combination of education and experience.
Experience managing clinical research projects involving investigational products within a Contract Research Organization (CRO) or pharmaceutical environment.
Clinical trial experience and demonstrated ability to manage multiple projects, timelines, and stakeholders.
Working knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and U.S. Food and Drug Administration (FDA) regulations.
Experience with project planning, budgeting, forecasting, financial tracking, and resource management.
Proficiency with Microsoft Office applications, including Word, Excel, and Project.
Knowledge of medical imaging technologies or imaging-focused clinical studies is preferred.
Strong communication, presentation, stakeholder management, and relationship-building skills.
Demonstrated leadership, organizational, problem-solving, and decision-making capabilities.
Ability to work effectively in a collaborative, fast-paced, and results-driven environment.
