ETMF Координатор (ассистент по работе с электронным файлом исследования)

Компания "АстраЗенека"

At AstraZeneca we believe in the potential of our people and we’ll develop you beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. In Russia, we bring together over 2000 talented people who share our passion for science and our dedication to put patient needs first.

Responsibilities:

• Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (TMF);
• Timeliness in deliverables through process planning and goal setting
• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
• Perform quality control of documents submitted to the eTMF using the established acceptable criteria,
• Ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs;
• Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
• Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
• Administrative support for RWE studies related activities
• Support with CRO managed RWE studies

Requirements:

• Previous experience working in Veeva Clinical Vault (eTMF)
• Solid understanding of the clinical trial / observational study process.
• Experience in handling studies (clinical or RWE) related documents required and knowledge of Trial Master File
• Strong knowledge of ICH-GCP guidelines and requirements related to study document management
• Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP) and Good Documentation Practices
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment
• Strong organization skills with outstanding attention to detail and follow through
• Demonstrated effective communication skills to internal and external team members
• One years of relevant work experience in a RWE or clinical studies positions or an equivalent combination of education and experience
• Possess good critical thinking skills with a focus on inspection readiness
• confident user of Microsoft office (Excel, Word), Outlook
• A willingness to perform monotonous work, ensuring high quality of work
• English language skills not lower than upper intermediate

What we offer:

• Opportunity to work in an international innovative company with life-saving product portfolio.
• Team of experts: opportunity to build processes, use modern technologies and tools with deep business involvement.
• Competitive compensation based on experience with bonus scheme aligned with corporate policy.
• Professional and career growth opportunities.
• Flexible benefits program: compensation of sports, healthcare, travel expenses, etc.
• Corporate car and mobile phone are provided.
• Health, life and travel insurance from the first day.
• Well-being and employee assistance programs. PrimeZone discounts (sports, education, etc.).
• Wide range of training and development: language courses, the "AZ Grow" corporate learning platform, external training and conferences, volunteer programs, and etc.
• Modern office: Comfortable A-class office in the Moscow-City.
• Flexible working hours: start between 8:00 and 10:00.
• Hybrid work schedule