Clinical Project Manager
Baxter Parkway Riverwoods, IL 60015 US
Job Description
Summary:
Responsible for managing the organization and conduct of clinical studies in compliance with Clinical Operations policies and procedures, Regulatory (Health) Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives. Reports directly to the Director of Clinical Operations in Deerfield, Illinois. The Clinical Project Manager plans for and executes the required global or domestic clinical development plan of drugs and devices to generate data to support the launch and expansion of critical treatments for patients. This data serves to globally support regulatory submissions, post-marketing complaint handling and promotional claims for marketing strategies. The Clinical Project Manager also consults with regulatory, engineering, marketing, sales and research groups in problem solving efforts. Essential Duties and Responsibilities:
- Partner with relevant functions to develop clinical study plan for each project including timelines and budgets for the clinical program.
- Prepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrolment feasibility evaluations and all relevant internal plans required for study conduct.
- CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.
- Site activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements and negotiate study budgets.
- Study monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activities
- 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.
- Develop and maintain tracking systems as needed for study management, e.g. screening, enrolment, study completion, (serious) adverse events, budgets and forecasts, milestones.
Qualifications, Education and/or Experience:
- Minimum: BA/BS in scientific field with minimum of 5 years clinical operations experience (pharmaceutical, biotechnology or medical device industry) preferably with 1-2 years of direct CPM experience.
- Has familiarity with 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)
- Has understanding of the development process from Phase 1 through Phase 4 for drug and/or device trials
- Possesses working knowledge of research objectives, protocol design, and data collection standards
- Experience with clinical operations systems including EDC, CTMS, and eTMF
- Experience in project management practices
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