- Adgar Wave, Wincentego Rzymowskiego 53, 01-001 Warszawa, PolskaWarszawa, mazowieckie
- Ogłoszenie wygasło 8 dni temu
- Umowa o pracę
- Pełny etat
- Specjalista (Mid / Regular)
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
We are currently building a Central Monitoring Team with the hub to be based in Poland and looking for several candidates. The Central Monitor will be responsible for conducting holistic and centralized review of study data according to the study Monitoring Plan, using data analytical tools to identify emerging and existing risks to critical study data and process.
Central Monitor SpecialistNumer ref.: 259765
- Supports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized monitoring.
- Acts as a Risk Based Management data analytical tool expert for conducting data risk review, risk and issue management.
- Participates in the training of central and local study teams on Risk Based Quality Management and central monitoring processes.
- Performs centralised monitoring of study data and maintains oversight of study/country/site risk parameters according to the study monitoring plan.
- Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues.
- Communicates to relevant study team members trends/findings, implications and recommends actions within data analytical tool and provides regular status reports to study team.
- University degree in a scientific discipline is preferred.
- Min. 2 years of drug development experience in pharma, as well as relevant CRO/ ARO or clinical trials experience.
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
- Understanding of the clinical study, drug development, risk management and other associated processes and quality requirements.
- Good understanding of scientific and medical information, and the ability to apply this understanding to the conduct of instream quality risk management.
- Understanding of various local regulatory environments, compliance with ICH GCP.
- Understanding of Risk Based Management, use of data analytics (e.g. Spotfire RBM Tool) and Risk Based Quality Management (RBQM).
- Able to set and manage priorities and performance targets, effectively plans, communicates, coordinates and facilitates delivery of team objectives.
- Fluent communication in English.
- We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer;
- Opportunity to join new department, participating in its development and constant improvement of ways of working.
- Personalized learning approach (e.g. mentoring, online trainings’ platforms).
- Wide offering of company benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, recognition awards for additional achievements, flexible working hours, home office);
- Corporate culture based on our values: patient focus, integrity, respect and transparency.