Senior Global Study Manager - Oncology R&D
Job Type: Full time
Are you ready to join our Early Oncology Study Management team at AstraZeneca and make a difference for patients living with cancer?
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!
Where Science thrives…Cambridge is one of the most exciting bioscience hotspots in the world, playing a central role in our mission to deliver life changing medicines to patients across the globe. This role could be located in either the Melbourn Science Park or the Central Cambridge offices.
Located in stunning offices set in 17 acres of landscaped grounds. The Melbourn Science Park offers an impressive mix of refurbished open plan office space on two floors and a suite of fully furnished conference and meeting rooms. The building benefits from a full height atrium and stunning views overlooking the lake.
Central Cambridge – Located in walking distance from the Train station, you will have access to an onsite gym, restaurant facilities and experience working within a calm and relaxing agile environment, inspired by the University Botanical gardens.
Both sites provide access to a stylish, fully air conditioned fitness centre, an onsite restaurant, Lunch & Learn development activities, all within a forward-thinking and spacious environment while utilising the most advanced technology.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!
The Early Oncology Clinical Programs & Study Operations group are accountable for delivering high quality, cost efficient early phase clinical studies (phase 1 to phase 2b) that support drug development within Oncology.
We are looking to recruit Senior Global Study Managers (Senior GSM) to join our Early Oncology Clinical Group. The Senior GSM is a key member of the cross functional study team and supports the Study Lead who is accountable for cross functional leadership and overall study execution.
What you’ll do
The Senior GSM is responsible for delivering the operational activities, as well as providing guidance and support to the Global Study Managers (GSM) and Global Study Associate (GSA) assigned to the study. The exact accountabilities will differ depending on the exact nature of the clinical programme, so a high degree of flexibility is required.
Provide operational expertise to the study team.
Lead 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.
Create team culture and promotes team spirit within the GSMs and GSAs assigned to the study team.
Provide mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.
Run 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 Specification), and work 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 collaborating closely with Drug Supply or external service providers as appropriate.
Oversight of 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.
Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
Coordinate 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 quality, timelines or budget.
Drive risk management and quality efforts to ensure study compliance.
Lead set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
Prepare presentation material for meetings, newsletters and websites.
Advise the study team in the implementation of audits and regulatory inspections.
Identify areas of process improvements and knowledge share across the group.
Contribute to review of new/amended/unique SOPs and guidance documents
Required Experience, Skills, and Qualifications
Have a University degree in a related subject area, preferably in medical or biological science, or one related to Clinical Research.
Possess a deep understanding of the drug development process with 3-4 years clinical trial experience in Study Management, as well as an excellent knowledge of ICH-GCP.
Be fluent in written and spoken English, with experience of working with and delivering through strategic partners and 3rd party vendors.
Excellent knowledge of ICH-GCP principles
Demonstrate the following behaviours
Proven problem-solving skills and proactive approach
Ability to balance multiple deliverables
Ability to lead change and actively seek and champion more efficient and effective methods/ processes
Good communication, negotiation, collaboration and interpersonal skills
Ability to empower, coach and mentor junior staff
All employees will be required to be on site a minimum of 3 days per week.
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next:
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.
Closing date: 15th October 2022
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
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.