Senior Global Study Manager, Oncology R&D, Early Oncology Clinical
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Location: Barcelona Spain (On-site): 3 days/week working from the office.
Role Description
The Senior Global Study Manager is responsible for leading the operational activities to support and enable the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.
Typical Accountabilities
Provides 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.
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 Specification) 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.
Oversee 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.
Education Qualifications Skills and Experience
Essential
University degree / Bachelors degree preferably in medical or biological science or discipline associated with Clinical Research or equivalent experience
Deep understanding of the drug development process with minimum of 5 years clinical trial experience of which at least 2 years are in global study management
United States only: Bachelors Degree and 5 years of experience Associates degree plus 9 years of experience or High School plus 13 years of experience of which at least 2 years are in global study management
Experience of working with and delivering through strategic partners and 3rd party vendors
Excellent knowledge of ICH-GCP principles
Team orientated
Ability to lead coordinate and prioritise multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills
Good negotiation and collaboration skills
Demonstrated interpersonal and problem-solving skills
Ability to manage change and actively seek and champion more efficient and effective ways of working
Ability to coach & act as a buddy for more junior colleagues
Some travel may be required
Desirable
Early phase oncology clinical trial experience
Date Posted
05-sept-2025Closing Date
29-sept-2025AstraZeneca 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.
Required Experience:
Exec
Key Skills
- Hospital Experience
- Acute Care
- Basic Life Support
- ICU Experience
- Infusion Experience
- Triage
- TFS
- Conflict Management
- Nursing
- Critical Care Experience
- Epic
- Medication Administration
About Company
AstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.
