Quality and Training Manager
Position: Full time
Open date: Sep 2, 2019
Functional area: Medical and Clinical
• Works with the Country Head of Clinical Operations to ensure that Clinical Research activities are conducted by Country Clinical Operations Staff in accordance to ICH GCP, relevant international and local regulations, requirements and guidelines, as well as GSK written standards.
• To assess potential regulatory compliance issues and risks in clinical research activities conducted by Country Clinical Operations Staff and to ensure these risks are properly managed, documented and escalated as appropriate within GSK.
• To ensure that Country Clinical Operations Staff are appropriately trained to effectively conduct clinical research activities and receive ongoing training to meet the changing regulatory environment and updates to GSK written standards.
• To maintain an external focus, vigilance and networks to identify emerging trends in quality and compliance.
• Responsible for quality oversight (GCP related) in fully outsourced studies
• Responsible for all Clinical Operational quality issues locally and ensuring Clinical Research activities are conducted according to ICH GCP, local legislation and GSK written standards.
• Responsible to implement ongoing quality improvement processes, maintain local written standards and support all assessments and inspections.
• Ensure trainings for site staff are appropriate and meet their needs. Identify and address any additional local training needs.
• A minimum of 5 years' experience in Clinical Operations.
• Advanced knowledge of the drug development processes and key operational interfaces.
• High degree of organizational awareness; good understanding of clinical/corporate governance principles and demonstrated ability to develop solutions to complex problems with regard to quality and governance.
• Ideally have previous experience in quality management, knowledge of GSK written standards and experience in delivering clinical research training. Preferable quality auditor in Clinical trials experience.
• Extensive knowledge of ICH GCP requirements with strong knowledge of local and global regulatory requirements applying to Clinical Trials.
• Proven negotiation skills.
• Excellent written and verbal communication skills in English.
• Fluent in local language.
• Advanced user of MS Office (PowerPoint, Excel, Word & Outlook).
• Can work both independently on projects and also part of a team.
• Creative, logical, strategic thinker.
• Good eye for detail and high learning agility.
• Able and willing to travel as required for the role.
• Collaborative and open leadership style.
Please see basic qualifications.
• Working in a leading company from healthcare sector
• Possibility of developing within the role and company's structure
• Supportive and friendly working environment
• Company culture based on GSK values: patient focus, integrity, respect and transparency
• Atmosphere of trust which let you grow professionally and act independently
• Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund)
You may apply for this position online by selecting the Apply now button.
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