Scientist
- Brentford, England (GBR)
- £19 - £24 Per Hour
- 6 Months
- Start date: ASAP
- Ref: GSKSCICPG
- clinical trial
- sops
- argus
- data collection
- compliance
- case management
- process improvement
- data base
- licensing
- metrics
- operations
- training
- vendor management
CMG Scientist
Remote Based / Brentford
6 months initially
Up to £24 per hour
This position is responsible for ensuring both global and local regulatory reporting requirements for spontaneous, post marketing surveillance, and clinical trial adverse event data are met.
This role supports vendor management activities and quality oversight (e.g. through in-process checks), training of staff in both case handling, and operational activities. This role is also responsible for inputting into process improvement initiatives that impact SMG. This role liaises with SERM, Clinical Operations, Regulatory, Compliance, local operating companies (LOCs), vendors and licensing partners across all business units.
Accountabilities:
• Supports the relationship with outsourced vendors conducting case management activities and for ensuring vendor compliance with case management processes associated with safety case management and regulatory submission activities for human subject information (HSI) from all sources
• Support for vendor delivery of case processing activities and achieving KPIs
• Meeting with vendor counterparts daily/weekly to review workload and prioritization, service metrics, and ongoing operations
• Contribute to vendor training activities
• SMEs aligned to case types; process owner for CMG processes and procedures
• Point of contact for vendors (training/trouble shooting/ARGUS related queries/process enhancements)
• Support process improvement projects for Processes/Systems including upgrades to the safety database
• Support to Japan CMG for case handling practices
Skills & Experience:
• Degree in life sciences or medically-related field. Health care professional (e.g. pharmacist or nurse preferred).
• Knowledge of spontaneous, post marketing surveillance, and clinical trial adverse event reporting processes
• A general understanding of worldwide regulatory requirements
• Preferred experience working in a quality framework setting
• Vendor management experience is a plus
• Understanding of medical and drug terminology
• Knowledge of GSK products
• Knowledge of GSK safety database preferred
• Previous experience working in a complex, multicultural, matrix environment
• Experience developing and delivering high-quality training
Competencies:
• Working knowledge of principles of data collection, manipulation and retrieval
• Argus experience preferred
• Possesses strong computer skills and computer literacy
• Working knowledge of local regulations, relevant GSK SOPs and SMG guidance documents
• Demonstrates technical understanding of safety processes including regulatory interpretation, SOP/GUIs, Systems/data base conventions
• Prepare and present data/information within and outside of SMG
• Demonstrates excellent oral and written communication skills across cultural and language boundaries
• High degree of accuracy and attention to detail
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
Join GSK’s vision to do more, feel better and live longer:
https://www.youtube.com/user/gskvision/
Who will I be working with?
http://www.gsk.com/en-gb/careers/meet-our-people/
