- 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
- Oversee the delivery to plan of studies performed through external partners and to monitor progress, identify and solve operational issues.
- Lead and manage all activities related to site management and monitoring including the following with agreed timelines, agreed budget and company standard quality.
- Plan and deliver a site selection strategy
- Patient recruitment strategy including SMO managements
- Lead and manage CRAs including CRO CRAs to deliver clinical study data
- Develop and manage risk mitigation plans and contingency plans to execute site managements and monitoring from sites clarification to sites close on time.
- Manage the quality of clinical study data including queries and deviations and resolve issues as needed.
- Ensure the quality of monitoring visit reports focused on study specific contents.
- Lead activities associated with site audits in liaison with Clinical & Pharmacovigilance QA and contribute to regulatory inspection in the area of site management and monitoring
- Escalate issues related to site management and monitoring to an appropriate person and contribute to resolve.
- Responsible for ensuring timely compliance by clinical delivery sub team with mandatory governance controls
- Provide input and maintenance of up to date and appropriate quality, project and study plans(including timings and total costs) in agreed systems
- Lead a work package or manage a clinical study including scope, budget, timelines, risk management and communicate status and make a consultation with relevant function as required.
- 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.
- Ensure translation into Japanese of study documents.
- Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
- Manage the study delivery related activities associated with regulatory inspections/audits in liaison with Quality Assurance and other relevant parties.
- May be assigned responsibility for project management and leadership of non-drug project work including applying lean sigma and change management techniques.
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- At least 5 years' experience from within the pharmaceutical industry or similar organization or academic experience.
- Extensive knowledge of clinical operations, project management tools and processes
- Good experience of clinical development / drug development process in various phases of development and therapy areas
- Developing partnering
- Financial/Fiscal Awareness and Supplier/Partnership Management
- Business English (achieve common understanding at the context level)
- Native level Japanese
[Preferred Knowledge, Skills and Abilities]
- Oncology experience
- Knowledge of process improvement methodology such as Lean Sigma/Change Management
- Project management certification
(Experiences and skills will be considered)
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