retirement pension plan
PoznańPoznań, Greater Poland
- Offer expired 10 days ago
- contract of employment
- team manager
Assess potential regulatory compliance issues and risks in clinical research activities conducted by Regional Clinical Operations Staff and to ensure these risks are properly managed, documented and escalated as appropriate within GSK.
Ensure that Regional 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.
Actively contribute to the Global Quality and Training Network, taking on a leadership role for specific training and quality activities as part of the network. Also be a member of any local quality teams.
Maintain an external focus, vigilance and networks to identify emerging trends in quality and compliance which impact the GICCO business area.
Mentor and train colleagues throughout the Regions and act as the SME for the teams.
Take responsibility for all Clinical Operational quality issues locally and ensure Clinical Research activities are conducted according to ICH GCP, local legislation and GSK written standards.
Take responsibility for the development and maintenance of local Risk Register, Quality Plan and deliver all aspects of business management monitoring activities in partnership with the business.
Take responsibility to implement ongoing quality improvement processes, maintain local written standards and support all assessments and inspections.
Be accountable for design (when required), development (when required) and delivery of training identified globally and at a local level to support clinical operations processes and GSK written standards.
Identify and address any additional local training needs.
Mentor team staff across the regional teams.
Scientific Degree or equivalent experience ideally with some quality experience. Advanced degree preferred but not essential
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.
Extensive knowledge of ICH GCP requirements with strong knowledge of local and global regulatory requirements applying to Clinical Trials.
Sound understanding of the Internal Control Framework
Excellent knowledge of global and local GSK written standards.
Proven negotiation skills
Good written and verbal communication skills in English and fluent in local language
Advanced user of MS Office (PowerPoint, Excel, Word & Outlook)
Effective problem solver and conflict resolution
Masters of Science or equivalent
extra social benefits
one shorter working day
The changes proposed under Future Ready are to integrate the Rx and Vx organisations and are driven by a belief that working together to drive a common approach to all GSK R&D will ultimately help us create better, more productive R&D for patients, by being more effective in how we allocate our budget, share technical expertise and deliver our pipeline. It includes the creation of a world class OneDevelopment organisation which will deliver one, consistent world-leading development support for GSK’s pipeline. Global Clinical Operations is integral to the success of the OneDevelopment organisation.
Global Clinical Operations is transforming to fulfil our vision to “Be the best performing and trusted Global Clinical Operations organization”. Our mission is to “Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data”.
As the Quality, Capability & Risk Manager you will work with the Director Regional Risk Management & Management Monitoring to ensure that Clinical Research activities are conducted by Regional Clinical Operations Staff in accordance to ICH GCP, relevant international and local regulations, requirements and guidelines, as well as GSK written standards.
To work across Regional Teams to share best practices and collaborate with other Managers on ways of working.