Local Study Manager Praha
2011-07-27
Our client is international original pharmaceutical company based in Prague and we are looking for new member to join our Clinical Operations team - Local Study Manager.
As a Local Study Manager you will be responsible for study start after study allocation to Czech Republic, Complete study documentation together with person from EIRA and local staff, Submit CTA to SUKL for opinion and obtain ECs approval, Build budget for study and make agreements with centres and investigators, Attend monitors meeting before study start (together with study monitor) , Lead appointed monitors (CRO/CRA) in preparation phase of study – delegate tasks, control performance. You will be responsible for 100% requirements set up before centre initiation (IND approval, functional operational systems, training completed etc).
After study initiation is responsible for CT running within committed target and agreed milestones. Well-timed study site initiations, participate at initiation visits as needed. Coordination of outsourced monitoring and oversee adequate quality of running CT, Implement recruitment strategy to meet a proposed commitment, including warning of unproductive sites and taking correction actions. Keep updated SUKL, ECs and investigators with study changes.
After study completion is responsible for: Finalization of payment of all completed work and conclusion of study budget.
Successful candidates will hold a Degree in a scientific or healthcare discipline and will have a minimum 2 years monitoring experience and strong communication skills. This is an office based role. You will travel 20% of the time. A strong written and verbal communication skill in Czech language including good command of English is a must.
In case of interest please contact Lucie Ondruchova, M: ondruchova@hays.cz
