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Astellas is announcing a Manager/Senior Manager, Clinical Study Management opportunity at our Deerfield, IL location.

Responsible for overall program management with oversight of individual studies. Responsible for document preparation, processing and review. Manages direct reports. Anticipates and plans for resourcing needs. Responsible for reviewing and managing program budgets. Oversees vendor evaluation, selection and management.

Project Management: Responsible for oversight of individual studies as well as the overall program-related activities. Guides cross-functional team to meet program objectives. Manages escalation of study-related issues, sets team goals, timelines and priorities; establishes appropriate course of action for assigned projects; identifies resource needs for each project and coordinates available resources. Ensures the quality of key study team deliverables such as the study plans, protocol, CRF data and clinical study report. Ensures therapeutic area and other relevant training for internal and external project team members. Responsible for the conduct of investigator meetings and CRA/CRO meetings; plans and prepares for expert meetings including identification of KOLs, meeting materials and meeting conduct.

Document Preparation, Processing and Review: Oversees the preparation of study protocols, CRFs, data preparation plans, statistical analysis plans, clinical study reports and other program-related materials. Provides substantive input into relevant sections of pre-IND briefing documents, INDs, NDAs and other documents intended for regulatory submission.

Corporate Organization: Manages a Clinical Studies staff of 2-4 direct reports. Anticipates and plans for human resource needs; organizes clinical staff for maximum effectiveness in meeting business needs; provides direction, leadership and learning opportunities to enhance individual development of direct reports. Prepares annual performance objectives, performance appraisals and personal development plans for direct reports. Functions as operational expert to drive the study or program. Able to provide guidance and develop direct reports within a team environment. Ability to transfer operational expertise.

Budget Review and Management: Develops and reviews program budgets; actively monitors program expenditures; ensures accurate short and long-term forecasting. Reviews and approves study site payments and vendor payments, as appropriate.

Vendor Management: Directs the selection and ongoing management of vendors including CROs, central laboratories, core ECG readers, patient recruitment vendors, etc. Works closely with CRO management in overseeing CRO staff in their study conduct including study implementation, study management and data management. Participates in assessment of vendor performance. Ensures quality and timeliness of data analysis and transfer.

 

 
Position Requirements  University/College degree with seven years clinical trials experience is desired. Proven time and project management skills, knowledge of drug development process and proven leadership ability is required. Working knowledge of ICH and GCP guidelines is required. Experience in people management is preferred. Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Travel required.  

 
          
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