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.
Essential Duties and Responsibilities.
Conduct Clinical Development programs. Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials. Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance. This includes but is not limited to:
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program.
Clinical Trial Protocols - Prepare directly or facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements.
Research Agreements and Study Budgets - Prepare research agreements and negotiate study budgets with sites.
Identify clinical investigators and assess suitability of study sites. Recognize and maintain strong business relationships with key opinion leaders.
Plan and conduct investigators meetings.
Order clinical supplies and ensure logistics plans are in place prior to study start.
Train study staff on product usage, data collection and specific procedures.
Perform Study initiation visits directly or by managing others.
Manage clinical study monitoring resources for protocol and regulatory compliance including adverse event reporting and follow-up. If services of a Contract Resource Organization (CRO) or Central Laboratory are used, this position will lead the process to select the CRO/Central Lab and establish the contract. This position will be expected to manage the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.
Develop and maintain tracking systems as needed for study management, e.g. screening, enrollment, study completion, (serious) adverse events, budgets and forecasts, milestones.
Ensure the safety monitoring plan/safety tables have been agreed to by Medial Monitor and Vigilance/Surveillance functions are appropriate.
Interface with data management to establish a clinical data management plan for each project.
Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits.
Prepare/coordinate final reports.
Prepare annual safety reports.
Formulate clinical monitoring plans within bounds of Clinical SOPs and Health Authority regulations.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
Expertise in US Federal Food and Drug Administration, ICH/GCP and European Regulatory Authority requirements as applicable to a study (or the countries a study is conducted in)
Well established knowledge in overall development process from Phase 1 through Phase 4 for drug and device trials
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Reviews monitoring reports
High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Utilizes current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and leadership skills
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
Minimum: BA/BS in scientific discipline with minimum of 15 years clinical operations experience (pharmaceutical, biotechnology or medical device industry) preferably with 3-5 years of supervisory/management experience.
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 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.