Clinical Science Program Specialist
2 months ago
Our Tucson, AZ client has a contract opening for a Clinical Science Program Specialist.
JOB DESCRIPTION:
- The Client Diagnostics 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 Clinical Development Leader in the department Clinical Development and Medical Affairs (CDMA).
Key responsibilities include (but are not limited to):
- 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 IVD-Regulation for both conformity assessment and post-market 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 IVD-Regulation.
- Assess clinical evidence and state of the art in medicine related to the IVD products to asses and demonstrate clinical benefit and safety.
- Work and align with Post-Market Surveillance & Vigilance (Global Regulatory & Quality) on post market obligations.
This role requires following 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
- The position is initially temporarily limited to a duration of 1 year, but may be prolonged depending on the project’s progress.
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