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HealthStar Communications, Inc. - Saint Paul, MN US
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Job ID: 431977 Opened: 04/24/2012 Business Unit: ACD Allina Medical Clinic Cost Center: The DoctorsS S Location: MplsAMC The Doctors Uptown Full/Part Time: ...
Responsible for driving the strategy and managing the execution of global clinical studies and clinical programs worldwide through clinical project managers and/or involving departmental or cross-functional teams in support of the organizations business objectives for product development and/or commercialization.
Key Responsibilities
* Leads and drives the project team in the planning, execution and management of all operational aspects of clinical trials.
* Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
* Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
* Ensures the project team maintains a continuous state of audit readiness.
* In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
* Informs and presents study progress and known risks to Clinical leadership.
* Recruits, manages and develops Principals, Associates and Specialists. Mentors and coaches all level of Project Management.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
* Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
* Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Management Requirements
* Not applicable.
Education and Experience, or Equivalent
6 - 9 Years with BA
4 - 7 Years with MBA
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
