Clinical Project Manager (Remote)

Baxter is a healthcare company focused on making a greater impact through its mission to save and sustain lives. The Clinical Project Manager will independently manage clinical trials across their lifecycle, coordinate internal stakeholders and external vendors, and ensure quality, compliance, efficiency, and accountability. The role also involves preparing study documentation, managing sites and vendors, and maintaining clinical study tracking systems.

Responsibilities:

• Work independently to manage all aspects of a clinical trial, from protocol creation to the site selection/vendor selection process, to database lock, and review of the final clinical study report
• Prepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrolment feasibility evaluations and all relevant plans required for study conduct
• Manage the interfaces with Legal, Research and Development, Data Management, Medical Writing, Medical Affairs, Clinical Compliance and Training, Regulatory, and Marketing
• Interact effectively with Sr. Management to provide updates and escalate issues
• Effectively manage external team/vendor activities, including the IRB, as well as study site team members, including physicians and research staff
• Site activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site trainings, prepare and execute research agreements and negotiate study budgets
• Develop and maintain tracking systems as needed for study management, e.g. screening, enrollment, study completion, (serious) adverse events, budgets and forecasts, milestones

Requirements:

• Bachelor's degree in clinical research, biostatistics, pharmacy, nursing or a related healthcare discipline, or equivalent experience required
• 3–5 years of experience in clinical research, with increasing responsibility in trial coordination, clinical development, protocol management or clinical project management
• Experience supporting multi-site clinical trials, managing external vendors and ensuring compliance with applicable regulatory requirements
• Working knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA and EMA regulations, and applicable clinical trial requirements
• Understanding of statistical principles, including concepts described in ICH E9, and their application in clinical study design and data interpretation
• Knowledge of clinical study design, endpoints, protocols and regulatory documentation requirements
• Strong project management skills, including experience with scope definition, scheduling, budgeting, risk management and key performance indicator tracking
• Experience coordinating effectively with sponsors, contract research organizations, investigators, study sites, regulatory stakeholders and internal cross-functional teams