Global Study Manager - Clinical Operations
Job Type: Full time
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. 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
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 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.
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.
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
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
Demonstrate the following behaviours:
Ability to coordinate and prioritise multiple tasks and deliverables
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
All employees are required to be on site 3 days per week.
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!
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.
Where can I find out more?
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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.