Oncology Study Start-Up Manager

About AstraZeneca

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialization of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.

Job Description / Capsule

The Oncology Study Start-Up Manager (Onc SSU Manager) has local responsibility for the delivery of site start up activities for assigned studies and are active participants in the study team(s). The Onc SSU Manager works in close collaboration with Monitors Support Services Research sites Local Health Authorities and Ethics Committees and the Local Study. Delivery Team to ensure that quality and quantity of site activation deliverables are achieved in a timely and efficient manner.

The Onc SSU Manager is responsible for ensuring that all requirements for site activation are in place for the agreed number of centres in clinical studies according to AZ Procedural Documents international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials and local site activation process.

An Onc SSU Manager with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Site Activation Team Leader (SATL) as appropriate locally.

Typical 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 with support of CSA
• 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.
• Primary reviewer of site level 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 AstraZenecas 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 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 A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.
• Set-up populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Veeva MS Teams Box 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.

Education Qualifications Skills and Experience

Essential:

• Bachelors degree in relevant discipline
• Experience of Study Management within a pharmaceutical or clinical background
• Knowledge of relevant legislation and new developments in the area of Clinical Development and
• Study Management

Desirable:

• Advanced degree within the field
• Professional certification
• Understanding of multiple aspects within Study Management

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

You can find alternative messaging to use in the Global Talent Attraction Story messaging section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So whats next

Are you already imagining yourself joining our team Good because we cant wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table Brilliant! We have one seat available and we hope its yours.

Where can I find out more

Our Social Media Follow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram you have site country or departmental social media then feel free to switch any of the above links.

Date Posted

Closing Date

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.