We have an exciting opportunity for an office based Global Operations Study Manager for our medium sized pharmaceutical company
The GOSM will be responsible for providing operational support to one or more study teams in IIIb/IV settings through all phases of clinical study management (Plan, Prepare, Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations and for assisting the Global Operations Study Leader in designated management tasks.
Main responsibilities include but are not limited to:
* Provides operational support to one or more global study management teams (SMT)
* Provides GOSL with regular clinical trial updates (for designated areas) and reports on study progress
* Assists in the coordination and management of activities to ensure CRO and vendor delivery against the contracted scope of work
* Assists in ensuring the proper conduct of the trial
* TMF Management
* Identifies and contributes to areas of best practice and process improvements
* Contributes to functional excellence activities
For this exciting job position we require the following qualifications from your side:
Experience
* Experience of working as part of large team with a proven ability to make an active contribution to the team's performance and team working
* Monitoring experience or equivalent experience in operational fields of clinical development
* Life sciences degree or nursing equivalent with ideally a minimum of 3 years experience in a clinical research or health care related industry, or equivalent combination of education and experience
* Expertise in ICH GCP (theoretical knowledge and experience in its practical application)
* Proficient computer skills across multiple applications
* Advanced English level
Keywords:
"Clinical trial assistant" "Clinical trial administrator" "CTA" "Clinical trials" "Clinical research" "Pharmaceuticals" "Biotechs" "CRO" Clinical research organisation" "GSA" "CSA" "ICH-GCP" "clinical research associate" "global study associate" global clinical"