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Global Study Manager, Oncology

Location Waltham, Massachusetts, United States Gaithersburg, Maryland, United States Job ID R-157505 Date posted 30/01/2023

Global Study Manager

US – Gaithersburg/Waltham (Office-based)

Are you ready to join our Early Oncology Study management team at AstraZeneca and make a difference for patients living with cancer?

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really bring big new ideas to life and change the course of medicine.

AstraZeneca’s vision in Oncology is to push the boundaries of science to change the practice of medicine, transform the lives of patients living with cancer, and to ultimately eliminate cancer as a cause of death. Our broad pipeline of next-generation oncology medicines has nearly 100 clinical trials ongoing and a robust pipeline of preclinical therapies!

Come and join our AZ team where you will play a pivotal role in this exciting period of development.

We are looking to recruit atalented and experienced Global Study Manager (GSM) to join our Early Oncology Clinical group. Working closely with the Study Leader, theGSM is responsible for supporting the operational delivery of phase I / II clinical oncology studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical programme, so a high degree of flexibility is required.

Key Accountabilities

  • Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.

  • Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.

  • Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.

  • Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.

  • Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.

  • Ensure the supply of Investigational productand study materials by liaising with Drug Supply or external service providers as appropriate.

  • Oversight ofthird party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.

  • Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.

  • Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.

  • Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.

  • Support risk management and quality efforts to ensure study compliance.

  • Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.

  • Prepare presentation material for meetings, newsletters and websites.

  • Support the study team in the implementation of audits and regulatory inspections.

  • Contribute to review of new/amended/unique SOPs and guidance documents.

Required Experience, Skills, and Qualifications

To be considered for this position, it is essential to have:

  • University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience

  • Minimum of 3-4 years of progressive clinical trial experience

  • Experience of working with and delivering through strategic partners and 3rd party vendors

  • Excellent knowledge of ICH-GCP principles

  • Be fluent in written and spoken English

Demonstrated the following behaviours:

  • Team oriented

  • Ability to coordinate and prioritise multiple tasks and deliverables

  • Proactive approach

  • High degree of flexibility

  • Demonstrated verbal and written communication skills

  • Good negotiation and collaboration skills

  • Demonstrated interpersonal and problem-solving skills

  • Some travel may be required

Making a difference every day by delivering life-changing medicines to millions of people globally, our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a culture that inspires innovation and collaboration. If this sounds like the place for you - don't hesitate to apply and join us to become part of a Great Place to Work!!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.