Accountabilities
- Preparation & Submission of the local RA submission file following clinical trial application files dispatch & amendments dispatch
- Preparation & Submission of the EC submission file following clinical trial application files dispatch & amendment dispatch
- Follow up on intermediate letters, questions and answers, authorization
- Filing of documents on AZ filing system
- Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents
- Assist in coordination and administration of clinical studies from start-up through site activation
- Actively participate in local Study Delivery Team meetings and work cross-functionally with Contracts, Feasibility, and Study Support Services in SM&M
- Activate study sites in compliance with AZ Procedural Documents
- Share information (metrics) on study site progress towards activation within local Study Delivery Team and SM&M leadership as required
- Drive delivery of regulatory documents at the sites. Proactively ensure submission and activation against effective planned timelines defined with the LST, and identify delays in start-up activities and the risks to the activation plan
- Preparation of country and site Informed Consent Forms, as locally appropriate
- Update Veeva Clinical Vault (VCV) and other systems with data from centres as per required per SAT process, as locally appropriate
- Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per SAT process and agreement with Local Study Delivery Team
- Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA
- Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment)
- Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva)
- Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities
- Ensure that all start-up study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File
- Contribute to the production of study start-up documents, ensuring template and version compliance
- Create and/or import clinical-regulatory documents into the Enterprise Regulatory Vault (ERV) according to the Global Document List (GDL) ensuring compliance AZ Procedural Documents
- Set-up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.g., Veeva, MS Teams, OneDrive etc.) and support others in the usage of these systems
Additional Responsibilities:
- Contribute to process improvements, knowledge transfer, and best practice sharing
- Proactively share applicable information that may be relevant to other functions
Essential Skills/Experience:
- Bachelor’s degree in a relevant discipline
- Experience in Study Management within a pharmaceutical or clinical background
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations
- Basic understanding of drug development process
- Good collaboration and interpersonal skills
- Good verbal and written communication skills
- Excellent attention to detail
- Excellent understanding of Clinical Study Management and study start-up
- Good negotiation skills
- Good ability to learn and to adapt to work with IT systems
Desirable Skills/Experience:
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
- Integrity and high ethical standards
- Good analytical and problem-solving skills
- Good financial management skills
- Basic change management skills
- Good intercultural awareness
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
- Good cultural awareness
- Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities
