Clinical Operations Manager (m/f)

REFERENZNUMMER:

343641/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Clinical project manager