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Job Details

CENTRAL MONITORING SPECIALIST - Netherlands or Belgium

Company: PRA Health Sciences
Location: Netherlands or Belgium
Reference: 2016-37181
Closing Date: 21 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent salary + 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 Central Monitoring Specialist and help realize your career potential.

Requirements:

CENTRAL MONITORING SPECIALIST

Locations:  Netherlands or Belgium 

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 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. 

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

Responsibilities:

  •   Working fully outsourced to one of our global pharmaceutical client, the Central Monitoring Specialist, plans, validates and manages the central monitoring process in conformance to all relevant laws, regulations, guidelines, policies and procedures. Responsible for planning and executing the central monitoring aspect of clinical trials being conducted under analytical risk based monitoring (ARBM).
  • The focus of this position is to assist with the development and implementation of the ARBM activities initially for pilots, and expanding the role to further support all studies. 
  •  The role will execute the central clinical trial monitoring activities across the various phases of the trial execution as outlined in the end to end process.  
  •   The range of tasks will include activities such as providing input into the integrated ARBM plan, monitoring guidelines and source data verification plan, ensuring historical site performance is gathered,  performing trend analysis, maintaining oversight on site risk parameters and ensuring appropriate actions are taken by the TCSM organization to investigate the potential risks, monitor operational risk parameters at a trial level, spot checks of monitoring visit reports, lead lessons learned activities related to central monitoring. 
  •   Scope of work will include tasks associated with pilot start-up, execution and close out, and in all phases of central monitoring for designated trials. 

Desired skills and qualifications:

  •  The successful candidate for this role will be able to demonstrate prior experience of working in Clinical trials experience (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience) in the pharmaceutical industry or CRO.
  •  Good understanding of clinical research operations including on-site monitoring and site management is preferred
  •  Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, etc.) and previous experience in analytical risk based monitoring (ARBM) is an asset.
  •  Fluency in 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 518468.
 
PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.



 

Apply for this job: CENTRAL MONITORING SPECIALIST - Netherlands or Belgium

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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