Clinical Project Manager

About the position

The position involves managing clinical trial projects, ensuring effective communication among stakeholders, and leading project teams to achieve successful outcomes. The role requires a thorough understanding of project guidelines, financial management, and adherence to regulatory standards, while also supporting business development efforts and maintaining quality service standards.

Responsibilities

• Identifying project guidelines and communication needs by reviewing study requirements and collaborating with stakeholders.
• Defining project plans including timelines, milestones, and limitations for project staff.
• Establishing project reporting schedules and providing updates to relevant directors and sponsors.
• Performing project analysis and management by identifying critical success factors and determining needed resources.
• Collaborating with department leaders for appropriate training of project team members.
• Performing financial tasks including monthly billing, forecasting, and project scope reviews.
• Communicating protocol clarifications and revisions to the project team.
• Coordinating site management of data collection with internal and external teams.
• Leading project teams by developing and delivering training, establishing performance expectations, and analyzing team performance.
• Supporting business development efforts by collaborating on company capabilities presentations and attending professional meetings.
• Overseeing project close-out activities and assisting with submission coordination.
• Performing supervisory functions including planning, monitoring, and appraising job results of direct reports.
• Maintaining quality service and departmental standards by adhering to SOPs and reviewing company policies.

Requirements

• Bachelor's degree required or commensurate experience level, preferably in life sciences, pharmacy, nursing, or healthcare.
• Previous management or project experience in clinical development of investigational medications required.
• 1-3 years clinical trials experience within a CRO or pharmaceutical research organization, preferably in a project management role.
• Working knowledge of GCP, ICH guidelines, and FDA regulations.
• Medical Imaging experience is a plus.
• Experience with computer software including Word, Excel, Access, and Project preferred.
• Strong interpersonal and communication skills, both verbal and written.
• Strong organizational and leadership skills, goal-oriented, and ability to maintain a professional attitude.

Nice-to-haves

• Experience in decentralized, hybrid, and site-based clinical trials.
• Familiarity with project management software.

Benefits

• Competitive compensation
• Medical, dental, and vision insurance beginning Day 1 of employment
• Flexible work schedules
• Attractive PTO plan