Global Study Associate - 12 Month Contract

Introduction to role

Are you ready to make a significant impact in the world of clinical research? As a Global Study Associate (GSA), you'll be an integral part of the extended global study team, driving the delivery of clinical studies within Late Development Oncology. From the development of Clinical Study Protocols to study archiving, you'll support the Global Study Director and Managers in executing clinical studies with precision and efficiency. Your role will involve navigating AstraZeneca's Project Management Framework, adhering to clinical trial regulations, and embodying our values and behaviors. Are you up for the challenge?

Note: This is a 12 Month Contract

Accountabilities

• Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work.

• Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.

• Interact/collaborate with Site Management & Monitoring, other internal staff and external vendors in collection of regulatory and other essential documents.

• Contribute to electronic applications/submissions by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR.

• Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements.

• Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools.

• Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.

• Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/payments in relevant systems.

• Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out.

• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs.

• Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors.

• Prepares, contribute and distribute presentation material for meetings, newsletters and websites.

• Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Essential Skills/Experience

• Education in medical or biological sciences or discipline associated with clinical research preferred

• Proven organizational and analytical skills

• Previous administrative training/experience

• Computer proficiency in day-to-day tasks

• Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines

• Excellent verbal and written communication in English

• Demonstrate ability to work independently, as well as in a team environment

• Ability to prepare presentation materials

• Demonstrate professionalism and mutual respect

• Willingness and ability to train others on study administration procedures

• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

Desirable Skills/Experience

• Bachelor level education (or higher)

• Proven study admin/assistant or relevant experience on a study level

• Experience in clinical study lifecycle

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Annual base salary for this position ranges from $81,684.80 to $107,211.30

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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Annual base salary for this position ranges from 81,684.80 to 107,211.30.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.