Oncology Study Start-Up Manager, Thailand

The Oncology Study Start-Up Manager (Onc SSU Manager) is responsible for the local delivery of site start-up activities for assigned studies and actively participates in the study team(s). Collaborating closely with Monitors, Support Services, Research sites, Local Health Authorities, Ethics Committees, and the Local Study Delivery Team, the Onc SSU Manager ensures timely and efficient achievement of site activation deliverables. This role ensures all requirements for site activation are met according to AZ Procedural Documents, international guidelines such as ICH and GCP, and relevant local regulations. An experienced Onc SSU Manager may also take on additional responsibilities associated with the Site Activation Team Leader (SATL).

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

At AstraZeneca, we follow the science to pioneer new frontiers. Our team dedicated to Oncology is driven by an ambition to eliminate cancer as a cause of death. With cutting-edge science fused with the latest technology, we aim to achieve breakthroughs backed by significant investment. Our collaborative research environment unites the world's foremost medical centers, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career committed to improving the lives of millions with cancer.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.