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Country Lead Monitor
PRA international
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
Description
Working fully outsourced to our client - a leading pharmaceutical company - Country Lead Monitor oversees the conduct of the country level activities to ensure the country meets committed enrollment and timelines and country study budget.
Country Lead Monitor is accountable and responsible for overall country clinical trial activities, oversees the CRAs and study progress within country from feasibility to study archive. Your involvement begins with managing the country feasibility and site selection team and process to ensure the assigned study is initiated according to timelines. This will involve providing sufficient training to all CRAs assigned to the trial and developing further training plans if needed.
Country Lead Monitor is managing and tracking the study country budget, oversee study oversight plan to ensure quality and compliance which will include monitoring visits and provide oversight for the CRAs involved in the project.
Moreover, Country Lead Monitor is responsible for corrective action plans to ensures timely and sufficient resolution of issues that may impact the quality and compliance of the data. On some studies you may also be supporting regulatory and ethics submissions process and also contract negotiations.
Working fully outsourced to our client - a leading pharmaceutical company - Country Lead Monitor oversees the conduct of the country level activities to ensure the country meets committed enrollment and timelines and country study budget.
Country Lead Monitor is accountable and responsible for overall country clinical trial activities, oversees the CRAs and study progress within country from feasibility to study archive. Your involvement begins with managing the country feasibility and site selection team and process to ensure the assigned study is initiated according to timelines. This will involve providing sufficient training to all CRAs assigned to the trial and developing further training plans if needed.
Country Lead Monitor is managing and tracking the study country budget, oversee study oversight plan to ensure quality and compliance which will include monitoring visits and provide oversight for the CRAs involved in the project.
Moreover, Country Lead Monitor is responsible for corrective action plans to ensures timely and sufficient resolution of issues that may impact the quality and compliance of the data. On some studies you may also be supporting regulatory and ethics submissions process and also contract negotiations.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Language skills
English - Upper intermediate (B2) or Slovak - Upper intermediate (B2)
Personality requirements and skills
The successful candidate for this role will be able to demonstrate prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
It is essential that you have prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements. The position also requires awareness and understanding of cultural differences as well as regional operational differences and budget management.
Fluency in Slovakia and English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
It is essential that you have prior working knowledge of ICH-GCP guidelines and local and international regulatory requirements. The position also requires awareness and understanding of cultural differences as well as regional operational differences and budget management.
Fluency in Slovakia and English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.
Advertiser
Brief description of the company
PRA is a top five CRO that has worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community.
ID: 2578368
Dátum zverejnenia: 25.5.2016
2016-05-25
lokalita: Bratislava Pozícia: Marketing Manager, Project Manager, Regulatory Affairs Manager, Regulatory Affairs Specialist Spoločnosť: PRA international