Clinical Study Manager

1 settimana fa


Milano, Lombardia, Italia Quanta Part Of Qcs Staffing A tempo pieno
Clinical Study Manager
  • Pharmaceuticals
  • Various EU Locations We have an exciting opportunity with a North Carolina based client who's focus on the research, development, and commercialisation of products helps patients who haven't yet received necessary care.

You would contribute to their portfolio of life changing products as a Clinical Study Manager in their newest Europe facilities.


Responsibilities include:
Clinical project management of a clinical studyCreate and drive study level timelineDevelop overall feasibility concept and enrolment plan with input from COMsDevelop and manage study budgetProvide input on operational aspects of the protocolEnsure regulatory compliance and GCP complianceResponsible for oversight of TMF with periodic auditsResponsible for/contribute to vendor selection and management including issue escalationDevelop and manage Study Management plan and all associated documents oversight plan)

Collaborate with CS&L team to plan and coordinate IMP and non-IMP suppliesPlan facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetingsEnsure monitoring plan is developed and consistently executed in collaboration with COMsContribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMsAssigns and documents study specific roles and responsibilities to internal and external team membersQualifications, Skills and Experience:
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.

Other degrees and certifications considered if commensurate with related clinical research experience (e.g.diploma or associate degree RN, certified medical technologist).


Desirable:
Postgraduate qualifications.
Experience in scientific/medical research.
Specialist knowledge (e.g.vaccine and/or influenza).If this role is of interest to you, please apply now#LI-KT1
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