AstraZeneca
GlobalStudyManager
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“Global Study Manager at AstraZeneca. Skills: Clinical study management, Vendor oversight, Cross-functional delivery, Risk and quality management. Lead delegated aspects of global study delivery. Contribute to study documents and amendments”
What You'll Achieve.
Ensure every decision keeps timelines, quality and budget on track; Keep the study always inspection-ready; Accelerate decisive progress for people with blood cancers; Deliver to agreed timelines, budget and quality; Ensure efficient delivery to time, cost and quality objectives; Ensure compliance with ICH GCP, AstraZeneca SOPs, policies and guidelines; Reduce cycle times, enhance quality, and help deliver conclusive data
Industry & Context.
organizational and problem-solving skills
What They're Looking For.
Must Have
Minimum of 5 years progressive experience in clinical research, at least 3 years of clinical development project management experience, or equivalent, Extensive knowledge of clinical research regulatory requirements (incl ICH-GCP), demonstrated abilities in clinical study management processes and clinical/drug development, at least 1 year of experience as a Global Study Manager, Extensive and proven experience in driving operational delivery to timelines, costs, and quality, Proven experience leading delivery through internal and external organizations, Strong, demonstrated abilities/skills in matrix team leadership, abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, conflict management skills, Experience in providing clear requirements and selection of external contracts, Excellent communication and interpersonal skills, strategic and critical thinking abilities, organizational and problem-solving skills
Nice to Have
Higher university degree e. g. , PhD, MSc, Experience in all phases of a clinical study lifecycle, Basic knowledge of GXP outside of GCP (i. e. , GMP/GLP), Experience in haematology therapeutic area, Vendor management experience (e. g. , IRT, labs etc. ), experience in Hematology or Oncology areas
What You'll Do.
Lead delegated aspects of global study delivery
Contribute to study documents and amendments
Lead preparation of delegated study documents
Manage vendor set-up and budgets
Support Global Study Director/Associate Director with CRO
Partner with enablement teams and clinical experts
Plan and conduct internal and external meetings
Ensure supply of investigational product
Support risk management and quality efforts
Ensure documents are complete and verified
Support budget management and invoice reconciliation
Provide clear requirements for contracts
Support audits and regulatory inspections
Contribute to review of SOPs and guidance documents
Lead or participate in process improvement initiatives
How You'll Work.
Team & Collaboration
Join a highly collaborative team; Orchestrate internal functions and external partners; Partner closely with enablement teams and clinical experts; Align seamlessly with CROs and other providers; Establish and maintain effective working relationships with internal and external co-workers and stakeholders; Lead delivery through internal and external organizations; Matrix team leadership
Communication Scope
Excellent communication and interpersonal skills
Process & Methodology
Clinical development project management, Drive operational delivery to timelines, costs, and quality, Manage study timelines, quality, and budget
Full Job Description
Are you ready to drive complex haematology clinical studies from protocol to publication at pace, turning rigorous execution into results that impact patients? In this role, you will lead delegated aspects of global study delivery across countries and vendors, ensuring every decision keeps timelines, quality and budget on track. You will join a highly collaborative team focused on speeding promising science through clinical development. Empowered to take smart risks and move decisively, you will orchestrate internal functions and external partners to remove obstacles and keep the study always inspection-ready. Can you see yourself uniting data, operations and suppliers to accelerate decisive progress for people with blood cancers? **Accountabilities:** * Study Documentation Leadership: Contribute to the development of study documents and amendments, ensuring template and version compliance. * Lead the preparation of delegated study documents such as the Informed Consent Form, master Clinical Study Agreement and country-specific materials, as well as external service provider documents including specifications and study procedures. * Vendor and CRO Oversight: Manage the set-up of third-party vendors, assess statements of work and budgets, and run the change order process. For outsourced studies, support the Global Study Director/Associate Director in partnering with the CRO Project Manager to deliver to agreed timelines, budget and quality, maintaining and documenting appropriate oversight. * Cross-Functional Delivery: Partner closely with enablement teams and clinical experts across Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and align seamlessly with CROs and other providers to ensure efficient delivery to time, cost and quality objectives. * Study Start-Up, Maintenance and Close-Out: Plan and conduct internal and external meetings, including investigator and monitor meetings. Ensure the supply of investigational product and stud
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