Clinical Science Program Specialist

Our client a leading diagnostics and life sciences client is looking for Clinical Science Program Specialist.

Job Title: Clinical Science Program Specialist

Job Duration: Long Term Contract (Possibility Of Extension)

Job Location: Tucson AZ

Our client provides integrated solutions for diagnostic testing in commercial and hospital labs medical centers and laboratory networks. Our products and solutions support health care professionals in clinical decision making in a wide field of indications including cardiovascular infectious diseases metabolism and oncology. We are looking for a candidate to join the department Clinical Development and Medical Affairs (CDMA).

Responsibilities:

• Work with other Clinical Development Leaders Clinical Operations Regulatory Quality Labelling Lifecycle teams and R&D to generate Scientific Validity Assessments and Clinical Performance plans and reports according to the IVDRegulation for both conformity assessment and postmarket follow up.
  
• Support Indication Area Leaders and Clinical Development Leaders in the assessment and definition of Intended Uses (IU) clinical testing purposes of the IVD products and CDMA deliverables according to the IVDRegulation.
  
• Assess clinical evidence and state of the art in medicine related to the IVD products to assess and demonstrate clinical benefit and safety.
  
• Work and align with PostMarket Surveillance & Vigilance (Global Regulatory & Quality) on post market obligations.
  

Qualifications:

• Natural science or medical degree (PhD or PharmD) preferred
  
• First work experience within the pharmaceutical medical device diagnostics industry or academic hospital environment in particular with clinical development
  
• Fluent in English; additional languages are a plus
  
• Ability to build and foster multidisciplinary global relationships
  
• Broad biomedical understanding and interest across multiple disease areas strong analytical skills ability keeping the overview simplifying complex processes and organizing people and activities to achieve results
  

Company Benefits: Medical Dental Vision Paid Sick leave 401K

If interested please share your updated resume at /