Senior Global Study Manager - Early Oncology Clinical
- Experience Level
Senior 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.
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 Talented 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.
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.
- Builds a nurturing environment for development, by providing operational oversight and expertise to the GSM's, GSA's and team on the study.
- Creates a strong team culture and promotes team spirit within the GSMs and GSA assigned to the study team.
- Provides mentoring and guidance to the operations team ensuring effective collaboration and communication with the study team.
- Lead the development of study documents as appropriate as well as any updates/amendments
- Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
- Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
- Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
- Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and collaborate with data management representatives and sites to facilitate the delivery of study data.
- Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
- Collaborate 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.
- 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 necessary quality, timelines or budget.
- Drive risk management and quality efforts to ensure study compliance.
- Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
- Prepare presentation material for meetings, newsletters and websites.
- Direct the study team in the implementation of audits and regulatory inspections.
- Identify areas of best practice / process improvements and knowledge share across the group.
- Contribute to review of new/amended/unique SOPs and guidance documents.
In addition, the Senior GSM will:
- Have a clear understanding of each GSM's responsibilities - so prioritisation of tasks can be done in a fair, effective manner
- Maintain oversight of ongoing operational tasks and proactively identify and manage risks
- Encourage GSMs to share and adopt best practices
- Encourage and empower GSM's to be proactive with a solution driven mentality
- Consult Study Lead for sense-checks, issues, decisions as required
- Deputise for Study Lead at Programme level meetings as required
Required Experience, Skills, and Qualifications
To be considered for this position, it would be advantageous to:
- 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.
Demonstrate the following behaviours;
- Leadership capabilities
- Ability to prioritise
- Demonstrated problem-solving skills and proactive approach
- Ability to manage multiple deliverables
- Team oriented
- 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
- 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!!