ETMF Координатор

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 (STMF)
• 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
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Assists in coordination and administration of clinical studies from the start-up to execution and closeout.
• Assists in timely submission of proper application/documents to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Responsible for printing and distribution of documents and for processing and archiving of study/country related documents.
• Registration of incoming and outgoing correspondence

Requirements:

• Previous experience working in Veeva Clinical Vault
• Solid understanding of the clinical trial process. Experience in handling clinical trial related documents required and knowledge of Trial Master File
• Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management.
• Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP) and Good Documentation Practices
• Computer proficiency (Microsoft Word, Excel).
• Good knowledge of spoken and written English
• Proven organizational and administrative skills.
• 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
• 2 years of relevant work experience in a clinical development setting, or an equivalent combination of education and experience
• Possess good critical thinking skills with a focus on inspection readiness
• Proven organizational and administrative skills.
• Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Integrity and high ethical standards.

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.
• Mobile connection compensation.
• Outsoursed position, fixed-term employment contract.