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Job Details

COUNTRY LEAD MONITOR (CLM) - Czech Republic

Company: PRA Health Sciences
Location: Czech Republic
Reference: MH-2017-42168
Closing Date: 04 Sep 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits

Job Summary:

An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Country Lead Monitor (CLM) and help realize your career potential.

Requirements:

COUNTRY LEAD MONITOR (CLM)

Location: Czech Republic

As a top five CRO, we have 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 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. 

For more information please see our website: www.prahs.com

Responsibilities:

In direct collaboration with our pharmaceutical client we now have a Country Lead Monitor (CLM) role open. The position is based in our client's office in Prague, Czech Republic.

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 ensuring that the country meets committed enrollment and timelines and country study budget. 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.

Desired skills and qualifications:

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 Czech and English is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively.

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

If you have any questions please email recruiteruk@prahs.com or call our recruitment department at +44 (0) 1189 213652

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

Apply for this job: COUNTRY LEAD MONITOR (CLM) - Czech Republic

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

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