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Asst. Clinical Trial Manager / Clinical Trial Manager  /  社名非公開

ジョブNo.NJB1053108
職種 Asst. Clinical Trial Manager / Clinical Trial Manager
社名 社名非公開
業務内容 ・Responsible for overall management of the study/ project assigned from start up through study close-out, in compliance IDA processes and regulatory requirements.
・Communicates with clients, regulators, CROs and other vendors to ensure the successful conduct of IDA studies.
・Develop, review, and/or approve on Informed Consent Form (ICF), Case Report Form (CRF), Data Management (“DM”), and documents used in the study in coordination with the Project Team
・Ensure project timelines and quality of deliverables required by the sponsor/ client are met
・Oversee of site feasibility and selection process
・Assist in regulatory document maintenance including document collection and submission to regulatory authorities and Independent Ethics committee(IEC)/Institutional Review Board(IRB)
・Assist in Review labeling for compliance with regulatory requirements
・Assist in the Management of a process related the study drug including importation, returning to sponsor or destruction
・Provide or facilitate training to clinical study teams on assigned protocol specific topics
・Mentoring CRA including training, communication with site staffs and monitoring activities, as necessary.
・Responsible for implementation and compliance to key contract provisions while informing management and client for out of scope activities
・Communication and collaboration with the internal project team, clients, and vendors providing accurate labor forecasts, reviewing pass-through costs and ensuring timely invoicing
・Assist in the management importation/ exportation and accountability of IP and Non-IP clinical materials
・Oversee site visit compliance and review site visit reports
・Perform co-monitoring visits with CRA as necessary
・Perform periodic review of issues to identify any trends for communicating and taking appropriate action with CRA and escalation to Sponsor/ Client and/or QA as necessary
・Ensure completeness of Trial Master File(TMF)/Investigator Study File(ISF) and quality check on a regular basis
・Review and communicate with CRA to ensure timely CRF data entry and resolution of data issue
・Facilitate internal/external audit and inspection by regulatory agencies as required
・Other task as deemed appropriate by the line manager
求める経験 ・5+ years of clinical work experience in the Pharmaceutical / Medical Device industry and working knowledge of GCP/ICH guidelines and the clinical development process.
・Clinical Trial Manager requires previous CTM experience, Asst. Clinical Trial Manager can be just Lead CRA experience
・Have experience in Phase 1 to 3 clinical trials
・Bachelor’s degree or equivalent
・Strong communication skills in both Japanese and English
・Cross-functional team leadership experience preferred (at least 2 years)
・Management of international clinical studies preferred
・Experience managing vendors, including performance assessments and total financial management (invoice review, budget forecasting, etc.)
・Previous experience working with an electronic data capture system and CTMS system required
・Strong interpersonal, communication (written and verbal), and organizational skills
・Demonstrated ability to work independently as well as part of a multi-functional study team
・Able to motivate a team to work effectively under a changing environment
・Able to solve problems under pressure
・Self-motivated and able to work effectively in a matrix/team environment
・Availability for potential travel domestically and internationally
語学力 英語力:上級
勤務地
大阪府 東京都
年収 500万円 - 900万円
雇用形態 無期雇用

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