Description
We are looking for a
Clinical Operations Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in Basel
Branch: Herstellung von orthopädischen Erzeugnissen
Your tasks:
- Management of the operational trial related documents and procedures and supervision of all External Service Providers (ESP) and External Service Providers selection
- Leading the development of ESP specifications, testing and implementation in collaboration with other functions and ensure appropriate quality control of deliverables
- Responsible for the operational trial related activities such as site initiations and closures, eTMF set-up and maintenance, contracts execution and invoices and management or submissions to Health Authorities
- Leading the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.
- Supervision the deliverables towards the Contract Research Organizations (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work
- Acts as the communication channel for the CRAs to ensure data quality is maintained and ensure the CRAs are properly trained on the clinical trial requirements
- Approve invoices and ensure related payments in a timely manner
- Actively participate in Investigators meeting preparations and presentations
Your qualifications
- Bachelor of Science degree or equivalent university degree in life sciences or healthcare
- Profound experience in managing operational aspects of Phase II and III trials and executing a wide range of clinical trial activities from study start up to clinical study report
- Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management
- Previous experience in working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems
Skills:
- Clinical project manager