Full Job Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
The primary responsibility is to provide in-house support and assistance to Clinical Project Managers (CPM) with the day-to-day activities pertaining to clinical trials conducted for new product license applications, line extensions for existing products, and post marketing commitments with a focus on managing study documentation for completeness and accuracy, tracking study progress, assisting with site management and contributing to recruitment strategies as needed. Duties will be carried out under the supervision of a CPM.
Assist as required in the startup of clinical trials including support for investigator identification, investigator meetings, shipment of study supplies, collection of essential documents and preparation for site initiation
Assist with routine communication to study sites and broader study team (Vendors including Clinical Research Organizations (CROs) and support functions)
Support the CPM in development and/or improvement of study specific procedures and processes
Preparation, collection, processing, tracking and filing of study-related documentation, information and materials according to Good Clinical Practices and Standard Operating Procedures
Assignment and tracking of study team study specific training
Assist in preparation for internal and external audits
Handle queries or issues and when necessary, promptly triage to appropriate staff. Maintain appropriate systems including the Clinical Trial Management System (CTMS) to ensure adequate and accurate tracking of study progress, maintenance of study documentation and timely production of required reports
Develop and maintain a basic working knowledge of relevant protocols
Perform other project team duties as required or delegated by the CPM
Act as a back-up for CPM
Assist in reviewing regulatory documents for completeness and Good Documentation Practices
Internal and external communication, including meeting minutes
Help organize clinical team meetings
Comprehensive knowledge and understanding of Good Clinical Practices required
Ability to maintain effectiveness under changing circumstances and priorities
Excellent verbal and written communication and organizational skills required
Microsoft Office software expertise (specifically in Project and PowerPoint)
Meticulous attention to detail expected for this position
Excellent command of spoken and written English. Other languages are a bonus
Bachelors degree and 3-5 years of clinical experience in pharmaceutical, biotechnology or medical device company including CRO.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.