Core Responsibilities:

• Develop and maintain effective working relationships with all study stakeholders, including internal teams, vendors, collaborators, and sponsors.
• Oversee study contracts, budgets, amendments, and change orders to ensure alignment with project goals.
• Manage project meetings and communications, including scheduling, creating agendas, preparing materials, coordinating participants, documenting minutes, and tracking action items to completion.
• Facilitate regulatory submissions and other cross-departmental tasks required for study progress.
• Provide study metrics, visit projections, and reporting to support team decisions and executive leadership updates.
• Monitor project status across studies, sites, and business opportunities, identifying areas for efficiency improvements.
• Partner with finance to ensure accurate budget tracking, invoicing, and reconciliation of project milestones.
• Contribute to organizational growth by developing procedures and optimizing processes.
• Perform additional tasks as assigned.

Qualifications:

• Bachelor’s degree in a relevant field or a minimum of three years of clinical research experience.
• Proven interest or experience in project/program management, with strong organizational, leadership, and communication skills.
• Excellent time management, problem-solving, and critical thinking abilities, with a capacity for process development.
• Self-motivated and able to work independently as well as part of a collaborative team.
• Comfortable leading project meetings, including calls with sponsors, external collaborators, and internal teams.
• Hybrid role requiring both onsite presence and remote work capability.

Preferred:

• Five or more years of clinical research experience, including at least three years in project management of complex initiatives.
• Experience working with diverse stakeholders such as regulatory agencies, vendors, and collaborators.
• Knowledge of GDocP, GCP, and other clinical trial regulations.