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Job Details

Country Clinical Quality Manager

Company: Clintec
Location:
Reference: Oe-CCQM-Apr17-PH
Closing Date: 17 Nov 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Clintec is actively recruiting for a Country Clinical Quality Manager to join our expanding global company in Austria. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Requirements:

Country Clinical Quality Manager – Vienna, Austria – Home/ Office base – Permanent contract

Clintec is actively recruiting for a Country Clinical Quality Manager to join our expanding global company in Austria. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Job Description:

Audits, inspections, CAPAs: Manages and supports audit preparation activities. In cooperation with country functional area heads: initiates state of the art root cause analysis for Audit and Inspection findings (site and subsidiary Corrective and Preventive Actions and also the tracking until completion); coordinates and facilitates response to Audit and Inspection reports. Trend analysis, escalation: Undertakes country trend analysis and impact assessments of audit and/or inspection findings and analysis of FA QC activities like Co-Monitoring, to be taken into consideration for country/regional QC plan; initiates actions as needed. Communicate/escalates any trends to country Clinical Research management and RCQM as needed.

Responsibilities of the Country Clinical Quality Manager:

  • GCP Regulations, Country SOPs: Is GCP and local regulations expert at local level
  • Is the Local Lead for Management of Country Standard Operation Procedures (CSOP)
  • In cooperation with country functional area heads: ensures CSOPs are checked/updated regularly; signs/authorizes CSOP deviations along with process owner
  • Training, process improvement: Is the Local Quality/Process Improvement and training contact person.
  • QC, CROs: Defines an annual country QC plan endorsed by Country Clinical Research head
  • In agreement with the functional area, the CCQM may perform QC activities and field visits
  • Supports functional area in the qualification process of locally selected vendors and solving of quality issues with locally selected vendors

Essential Criteria:

  • Bachelor’s degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
  • A minimum of 6-8 years of relevant experience in 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.
  • Demonstrated experience leading cross-functional teams of business professionals
  • Incumbent must have a solid track record of initiating, planning and delivery of projects and knowledge of project management practices
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
  • Fluency in English and German (both written and spoken)
  • Willingness and ability to travel
  • Willingness and ability to be home based.
  • Desirable Criteria:
  • Experience across a wide range of clinical indications / therapeutic areas
  • Ability and experience to work with an electronic case report form (eCRF)
  • Membership of local professional bodies or international clinical groups
  • Ability to mentor, train, supervise and inspire confidence in newcomers to the industry

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package. 

Apply for this job:  Country Clinical Quality Manager

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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