Global Study Manager, Oncology R&D, Early Oncology Clinical

Accountabilities

Study Document Development:
Contribute to the creation and maintenance of core study documents and amendments, ensuring template and version compliance to enable consistent, high-quality execution.

Country Activation:
Lead the preparation of country-specific agreements, confidentiality agreements, clinical trial applications, and other local documents to secure timely approvals and site activation.

Vendor Strategy and Management:
Set up third-party vendors, define initial statements of work and budgets, manage change orders, and maintain strong oversight to keep delivery on time and on budget.

Data Delivery Interface:
Provide input to data management documents (including Case Report Forms and Data Validation Specifications), partner with data management and sites, and facilitate accurate, timely data flow for critical decisions.

Budget and Contracts:
Initiate contract and budget requests, track status, support purchase order generation, review vendor invoices, and monitor spend against the approved budget to maintain financial control.

Supply and Logistics:
Coordinate with Drug Supply and external service providers to ensure uninterrupted availability of investigational product and study materials at all sites.

Study Oversight and Quality:
Monitor study conduct and progress, proactively resolve issues that threaten timelines, quality, or budget, and drive risk mitigation strategies that protect patient safety and data integrity.

Insurance and Compliance:
Assist in the clinical trial insurance process; track approvals, revisions, and renewals; and support risk management and quality efforts to ensure compliance.

TMF and Inspection Readiness:
Set up, maintain, close out, and archive the Trial Master File with continual inspection readiness, ensuring complete and audit-ready documentation throughout the study lifecycle.

Communications and Engagement:
Prepare presentations and updates for meetings, newsletters, and websites to keep stakeholders aligned and informed.

Process Excellence:
Contribute to the review of new or updated SOPs and guidance documents to strengthen consistency and continuous improvement across studies.

• Contribute to the development of study documents 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, assess initial statement of work and budget, and oversee 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 data delivery.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices, and monitor spend against approved budget.
• Ensure the supply of Investigational Product and study materials by liaising with Drug Supply or external service providers.
• Oversee third-party vendors, global/local staff, and investigator sites to support effective delivery of a study from protocol to Clinical Study Report.
• Provide oversight of recruitment and data delivery and implement 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 impacting quality, timelines, or budget.
• Support risk management and quality efforts to ensure study compliance.
• Support the setup, 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.

• Experience leading global, multi-center early-phase (Phase I/II) oncology studies.
• Strong knowledge of ICH-GCP, clinical operations processes, and inspection readiness best practices.
• Proven vendor governance across biometrics, central labs, ePRO/IRT, imaging, and other specialized providers.
• Proficiency with EDC, eTMF, and risk-based quality management tools.
• Demonstrated ability to manage complex budgets and contract workflows across multiple regions.
• Excellent cross-functional communication, influencing skills, and stakeholder management at global scale.
• Degree in life sciences or related field, or equivalent clinical research experience.

Here, your leadership turns discovery into outcomes that matter for people with cancer. You will work side by side with scientists, clinicians, technologists, and operations experts who blend academic insight with industrial scale, supported by modern platforms and a pipeline designed to learn fast and advance the most promising ideas. Expect real collaboration across borders, a…