Manager, Clinical Operations Job in North Chicago 60073, Illinois Us
Manager, Clinical Operations
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Clinical Services Responsibilities include but are not limited to the following:
* Prepare and implement logistic procedures to control investigational product distribution, receipt, return and disposition.Monitor process performance and make adjustments as necessary.
* Coordinate preparation of investigational product with Clinical Supply Chain function to meet project timelines.
* Collect accountability information in order to reconcile investigational product.
* Represent Clinical Services on project teams. Identify barriers and recommend solutions to the team. Assist in the development of a project plan and execute to timeline. Communicate project status to project management and senior management. Assist with the preparation of the logistics.
* Process investigational product orders as needed.
* Monitor and ensure vendor/contractors perform against clinical protocol requirements.
* Train and educate involved parties on logistic procedures
If required, the incumbent may also provide operational support to clinical teams by performing one or more of these tasks
* Provide back up to clinical project managers, as needed
* Help track study expenses and budget.
* Support the study team in development and/ or improvement of study specific procedures
* Collect, process, track and archive study documentation.
* Assist in organizing Investigator Meetings and /or external trainings.
* Review regulatory documents for completeness and GDP
* Prepare 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. Good analytical, problem solving, negotiating, interpersonal and organizational skills. Must be results-oriented and have the ability to work with a high degree of independence. Excellent verbal and written communication and organizational skills required (English excellent, any other language is an asset). Knowledge of computer software (Enterprise Resources planning such as AS 400 or JDE is an asset) and meticulous attention to detail expected for this position.
* Bachelor's Degree in Life Sciences or related fields
* Two to three years previous pharmaceutical and/or medical device clinical development experience
* Knowledge of clinical supply logistic and distribution systems, home patient programs, and products/services preferred.
* Presentation skills or training experience preferred.
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.