Clinical Project Manager (Remote)

Job description

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. What you'll be doing: 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. What you'll bring: 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. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated pay range for this position is $120,000 - $165,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less within the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .