Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Country Clinical Quality Manager

Company: ClinTec International Ltd
Location: Guatemala
Reference: GUA-CQM-100117-DH
Closing Date: 07 Mar 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

ClinTec International is actively recruiting for a Country Clinical Quality Manager to join our expanding global company in Guatemala (Guatemala City) - permanent contract, office based opportunity. 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 – Guatemala

ClinTec International is actively recruiting for a Country Clinical Quality Manager to join our expanding global company in Guatemala (Guatemala City) - permanent contract, office based opportunity. 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. In cooperation with country functional area heads and close cooperation with the Companies Polytechnique Institute (MPI): identifies local training demand /Initiate local training activities; manages and tracks the training objectives of subsidiary staff
  • QC, CROs: Defines an annual country QC plan endorsed by Country Clinical Research head
  • In mutual 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:

  • Bachelors 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 Local languages (both written and spoken)
  • Willingness and ability to travel
  • Willingness and ability to be office based in Guatemala City  

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 International 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 over a decade. At ClinTec International, we pride ourselves on providing high quality, flexible and professional services and solutions to our clients. ClinTec International 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 International 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

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.