- Adgar Wave, Wincentego Rzymowskiego 53, 01-001 Warszawa, PolskaWarszawa, mazowieckie
- Ogłoszenie wygasło 8 dni temu
- Umowa o pracę
- Pełny etat
- Kierownik / Koordynator
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 Monitoring Lead will be responsible for implementation of Risk Based Quality Management (RBQM) across studies, focus on Centralized Monitoring and Data analytics. They will also act as a RBQM advisor to study teams, promotes effective risk planning and processes to proactively identify risk and create effective quality plans.
Central Monitoring LeadNumer ref.: 259767
- Act as single point of accountability for the application of Risk Based Monitoring aligned with the protocol, SOPs, ICH GCP and regulatory requirements for assigned GSK sponsored studies.
- Be a subject matter expert on Risk Based Monitoring, Centralized Monitoring and Data analytics to the central study team and in-country operational staff, such as the Clinical Research Associates (CRAs) / Senior CRAs, Local Study Managers (LSMs)/ Senior LSMs.
- Accountable for study level data analytics, vendor deliverables and performance; ensure monitoring (central and site) mitigations to study and data risks are fit for purpose and included in the appropriate operational plans (e.g. Study Monitoring Plan and Data Quality Plan).
- Participate in determination of data monitoring requirements for a clinical study, including input into the study risk assessment and monitoring mitigations as well as review of eCRF SV requirements.
- Work with Central Monitors and study teams to define and agree on remediation to address trends, signals and issues in the data.
- Mentors and trains Central Monitors as well as members of the central and local study teams.
- University degree in a scientific discipline is preferred.
- Min. 3-4 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.
- Business acumen demonstrated by understanding of risk management, problem-solving, the implications of decisions and uses this knowledge to plan and manage issues, projects and processes.
- 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.
- Strong knowledge/experience in project management and matrix team interactions.
- Excellent communication skills and able to explain complex situations.
- Leadership skills, promoting motivation and empowerment of others in order to accomplish 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.