【AstraZeneca】【R&D】Study Manager, Oncology or BioPharma

Description

Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.

To deliver clinical studies in Japan

• Manage a cross functional team of clinical experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality including documentations.
• Provide input into study start up activities performed by project team ( study feasibility, study specifications,).
• Responsible for study start up activities performed by Japan study team ( vendor / partner contracts, authoring of clinical study protocols and budgeting including authorization and governance of payment).
• Oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, manage risk / mitigation, identify and solve operational issues.
• Responsible for ensuring all activities related to site management and monitoring including the following with agreed timelines, agreed budget and company standard quality. In case of the study without Senior CRA assignment(including similar role in CRO), Study Manager is responsible to lead and manage all following activities related to site management and monitoring.
• Ensure the quality of monitoring reports from study specific perspective(, SQV / SIV reports).
• Lead and manage queries and quality issues related to study management and resolve issues as needed.
• Ensure the quality of clinical study.
• Manage a clinical study including scope, budget, timelines, risk management and communicate status ( via generation of reports) and make a consultation with relevant function as required.
• Lead activities associated with system audits / site audits in liaison with Quality Assurance.
• Escalate issues related to study management to an appropriate person and contribute to resolve.
• Ensure up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as Veeva Clinical Vault, PLANIT and ACCORD).
• Ensure translation into Japanese of study documents such as CSP and MICF.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
• Provide input along with the project team and functions the most efficient procedures to support delivery by taking the project situation and compliance requirements into account. This includes that ensuring sufficient appropriate training on AZ processes, SOPs, standards and templates is provided to external partners.
• May be assigned responsibility for project management and leadership of non-drug project work.

Qualification (Experience & Skill etc.)

Experience】

Mandatory＞

Nice to have＞

Education】

Mandatory＞

Skill-set】

Mandatory＞

Nice to have＞

Language】

Mandatory＞

English：Business English (Achieve common understanding at the context level with customers)

Career Level】

Date Posted

16-6月-2025

Closing Date