Country Clinical Quality Manager – Poland - Office based in Warsaw
- Contract Type
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 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.
- 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 Local languages (both written and spoken)
- Willingness and ability to travel
- Willingness and ability to be home based.
- 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
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.