Clinical Project Manager (Remote)
About The Position
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter This Is Where... As a Senior Specialist, Clinical Development, you will independently manage assigned clinical trials across the study lifecycle, from protocol development and site selection through study completion, database lock and review of the final clinical study report. You will serve as a key partner to internal stakeholders, clinical sites and external vendors, ensuring studies are executed with quality, compliance, efficiency and accountability.
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.
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.
Benefits
- medical and dental coverage that start on day one
- insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
- Flexible Spending Accounts
- educational assistance programs
- paid holidays
- paid time off ranging from 20 to 35 days based on length of service
- family and medical leaves of absence
- paid parental leave
- commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
