18 часов назад
Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences (Clinical Data Sciences)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences (Clinical Data Sciences): Developing and operating risk-based monitoring systems for clinical trials with an accent on key risk indicators, study-level system setup, and clinical data quality. Focus on reviewing monitoring signals, coordinating issue resolution, and ensuring compliance with ICH GCP, SOPs, protocols, and regulatory requirements.
Location: Thessaloniki, Pylaia, Greece; hybrid work arrangement
Company
is a pharmaceutical company focused on developing medicines and applying digital solutions to improve patient outcomes.
What you will do
- Set up and test study-level risk-based monitoring systems for clinical trials.
- Define and maintain key risk indicators in alignment with standard and study-level requirements.
- Review system outputs and manage signals, actions, findings, and issue resolution.
- Maintain quality-control documentation supporting data completeness and accuracy.
- Provide technical support, troubleshoot database issues, and communicate with global study teams and stakeholders.
- Support central monitoring oversight and ensure systems comply with protocols, ICH GCP, SOPs, corporate standards, and regulatory requirements.
Requirements
- Bachelor’s degree or equivalent experience in a scientific or business-related discipline.
- At least 3 years of experience in clinical trials, such as clinical research, data management, programming, or site monitoring.
- Experience supporting clinical trial database development, data management, site monitoring, or related activities.
- Knowledge of clinical study management, data management, and regulatory operations.
- Strong verbal and written communication, organization, prioritization, and multitasking skills.
- English is required for the application and motivational letter.
Nice to have
- Experience with clinical data management processes, including CRF design, database setup, edit check specifications, DMPs, and data cleaning.
- Knowledge of Phase I–IV clinical development and study design principles.
- Experience with clinical trial databases, Oracle, PL/SQL, SAS, Java, relational database design, or database programming.
- Knowledge of Windows applications including Word, Excel, PowerPoint, and Project.
Culture & Benefits
- Patient-centric culture guided by courage, joy, equity, and excellence.
- Flexible workplace culture supporting work-life harmony.
- Commitment to diversity, inclusion, accessibility, and reasonable workplace adjustments.
- Digital transformation initiatives using data, modeling, and automation in drug discovery and development.
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