Global Study Manager
- Experience Level
Global Study Manager
UK - Cambridge
Do you have expertise in, and a passion for, Early Oncology Clinical Operations? Would you like to apply your expertise to impact the lives of patients living with cancer, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
Do you want to be part of a team, that follows the science to transform the lives of patients living with cancer?
Welcome to Cambridge, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day. To help you maintain your best self, here's a sneak peek into some of the things this site provides for you…
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 bright and spacious environment while utilising the most advanced technology.
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. A place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.
We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.
It's our unique people-first approach that keeps us grounded and inspired to improve outcomes for all. Listening to our patients to evolve with their needs and tailor their medicines.
What you'll do
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.
- 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.
Essential for the role
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!!
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 imagining yourself joining our team? Good, because we can't wait to hear from you. Don't hesitate in submitting an application today!
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.
Closing date: 12th April 2021
Where can I find out more?
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