Global Study Manager

UK - Cambridge

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 a talented and experienced Global Study Manager (GSM) to join our Early Oncology Clinical group. Working closely with the Global Study Leader the GSM 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 product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Interface with third 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.
• 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 would be advantageous to:

• Have a University degree / Bachelor’s degree in a related subject area, preferably in medical or biological science, or one related to Clinical Research.
• Possess a minimum of 2 years operational clinical trial experience in a global Study Management role within Clinical Development, as well as an excellent knowledge of ICH-GCP.
• Have experience of working with and delivering through strategic partners and 3rd party vendors.
• Be fluent in written and spoken English

Demonstrate the following behaviours;

• Team oriented
• Ability to coordinate and prioritise multiple tasks and deliverables
• Demonstrated problem-solving skills and proactive approach
• High degree of flexibility
• Good communication, negotiation, collaboration and interpersonal 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!!

Date Posted

09-Oct-2020

Closing Date

08-Nov-2020

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.