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Job Details

Country Clinical Quality Manager - Hungary

Company: Clintec
Location: Budapest
Reference: HUN-CCQM-161017-KB
Closing Date: 14 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive

Job Summary:

Country Clinical Quality Manager – Balkans - Office based in Budapest

Requirements:

Country Clinical Quality Manager – Balkans - Office based in Budapest

Clintec is actively recruiting for a Country Clinical Quality Manager to join our expanding global company in the Balkan region. This is permanent contract, working sponsor office based in Budapest and will require travel to Croatia and Serbia.

Job Description:

The CCQM oversees all CQM activities in the Baltic cluster. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

Responsibilities of the Country Clinical Quality Manager:

Regulations & Processes:

  • Local expert for ICH-GCP and local regulations  
  • Manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs)
  • Local expert for any quality-related local processes
  • Identifies process gaps / opportunities for process improvement and properly escalates as required
  • Leads continuous improvements activities at the country level and supports or co-leads continuous improvements activities at the global/regional level

Training:

  • Local training point of contact
  • Identifies local training needs and initiates local training activities
  • Supports onboarding of local country operations personnel (quality-related topics)
  • Quality Control (QC) Activities: 
  • Coordinates and oversees all QC activities (local quality plan) by ensuring a proper execution of the In-house Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs).
  • Performs QC activities (incl. QCVs).
  • Looks in to local trends, performs root-cause-analysis, develops local action plan if required

Audits & Inspections:

  • Primary point of contact for MRL Quality Assurance and Regulatory Agencies
  • Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection
  • Performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
  • Regularly looks in to local trends, performs root-cause-analysis, develops local action plan if required
  • Quality / Compliance Issue Escalation:
  • Communicates/escalates quality/compliance issues
  • Escalates quality/compliance issues to MRL Quality Assurance and/or MRL Compliance
  • Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of Privacy Breaches, if necessary
  • MRL Compliance Steward (if applicable)
  • Clinical Supplies GCP Investigations
  • Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
  • Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies

Vendor Qualification:

  1. Leads local vendor qualifications and supports solving of quality issues with locally selected vendors
  2. Supports the Quality Management System (QMS) assessment for global and local vendor qualifications.

Essential Criteria:

  • Bachelor's Degree or equivalent in relevant health care area.
  • 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.
  • Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
  • Fluency in English, Hungarian, Croatian and Serbian
  • Willingness and ability to travel across Balkan countries (up to 50%)
  • Willingness and ability to be office based in Budapest

Desirable Criteria:

  • Ideally, experience in managing audits and inspections.
  • Ideally, experience in coordinating and delivering training sessions

Company Information:

Clintec l is a UK-based, dynamic privately owned full service Contract Research Organisation with 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 assist in their key product development efforts for two decades, At Clintec we pride ourselves on providing high quality, flexible and professional services and solutions to our clients. Clintec has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, 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 partnership 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 - Hungary

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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