PRA Health Sciences

Country Clinical Quality Manager

Location
Greece (GR)
Salary
Competitive
Posted
23 Feb 2021
Closes
25 Mar 2021
Ref
SG2021-73886
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

PRA and our employees have won numerous awards and accolades in the CRO industry and 2020 hasn’t been any different with gold winners in the Project Manager and Clinical Research Team of the Year at the Pharma Times awards!
We have won multiple awards across Europe, The America’s and Asia Pacific including BioPharma Asia/Phar-East Best CRO, Pharma Times Clinical Company of The Year and special recognition at the Vaccine Industry Excellent Awards.

If you're ready to be a part of something inspiring join us and Discover Your PRA.

Who are we?

We Are PRA.

We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

Who are you?

You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for clinical development. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

What will you be doing? 

The CCQM will oversee all Clinical Quality Management (CQM) related activities in Greece. The CCQM will work in close collaboration with the Clinical Research Directors (CRD) and the local clinical operations team. In addition, the CCQM will support CQM activities at the regional and/or global level as needed.

As a Country Clinical Quality Manager (CCQM), you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.

Specific responsibilities include:
Audits & Inspections: The CCQM will be the primary point of contact for Global Compliance and Regulatory Agencies, manage and support activities during the preparation and ongoing phase of an audit/inspection. In cooperation with the local team and/or headquarters, the CCQM will perform a root-cause-analysis for audit observations/inspection findings, manage and track the Corrective and Preventive Actions (CAPAs) as well as coordinate and facilitate the responses to audit/inspection reports.


Processes & Regulations: The CCQM will be the local expert for ICH-GCP and local regulations. In close collaboration with the CRD, the CCQM will manage the local SOP/SME network to ensure a proper implementation of global/local procedures and the regular update of local SOPs. The CCQM will also identify process improvement opportunities and/or process gaps and properly escalate as necessary.


Training: The CCQM will be the local training point of contact and the liaison between local GCTO and Learning & Development. In close cooperation with the CRD, the CCQM will identify local training needs and initiate local training activities.


Quality Control (QC) Activities: The CCQM will ensure the proper execution of the In-house Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs). Upon request and in mutual agreement with the CRD and the RCQM, the CCQM may also perform QC activities and site visits.


Vendor Qualification: The CCQM will lead local vendor qualifications of locally selected vendors and supports solving of quality issues with locally selected vendors.

What You Need to Have:

  • Bachelor's Degree or equivalent in relevant health care area.
  • A thorough understanding of clinical research including direct field monitoring experience or management/ oversight of such individuals, with a demonstrated record of accomplishments
  • Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
  • Experience in managing audits and inspections is preferred
  • Experience in coordinating and delivering training sessions is preferred
  • Superior oral and written communication and people management skills in an international environment.
  • Excellent project management and organizational skills.


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.