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:
- Administrative and office support for RWE observational studies in accordance with company standard operating procedures:
- Communication with sites, Customer representatives and the study team;
- Office management activities (such as printing, tracking, ordering and inventory of office supplies and study materials, scanning);
- Registration and management of incoming and outgoing correspondence;
- Courier shipment management for study related materials and documents;
- Registration and verification of received invoices;
- Technical tasks for related activities for RWE (NIS) studies
- Administrative support for company employees; including assistance in organizing meetings, interaction with couriers, etc.
- Maintain document management of the Study Sponsor's file (eTMF), perform document quality control, upload documents to the Sponsor's system:
- Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (TMF)
- Timeliness in deliverables through process planning and goal setting
- Perform quality control of documents submitted to the eTMF using the established acceptable criteria
- Ensure RWE 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
- Working with the Customer's electronic systems
- Administrative support for supplier’s management (technical support for assessment and management in the company’s system)
- Technical support in interactions with investigators, Ethics Committee and other organizations to support RWE studies conduct
- Administration of interaction with suppliers and researchers on contracts and payments (agreement, signing of contracts, PO management, payment of invoices)
- Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
Requirements:
- Experience in office management, administrative tasks
- Solid understanding of the clinical trial / observational study process
- 1 year of relevant work experience in a RWE or clinical studies positions or an equivalent combination of education and experience
- The ability and willingness to work in a multi-tasking environment
- A willingness to perform technical, monotonous work, ensuring high quality of work
- 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
- Previous experience working in Veeva Clinical Vault (eTMF)
- Previous experience working with contracts and payments in clinical/observational studies
- 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
- Possess good critical thinking skills with a focus on inspection readiness
- Сonfident user of Microsoft office (Excel, Word), Outlook
- English language skills not lower than 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.
- Professional and career growth opportunities.
- Health insurance from the first day.
- 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.
- Office work (5 days)