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ジョブタイプ: Full-time
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仕事内容
Essential Functions of the Job :- Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
- Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
- Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.
- Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
- Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
- Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
- Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
- Participate in data review and discrepancy resolution.
- Participate in coordinating efforts with internai Pharmacovigilance, and safety group.
- Monitor study-specific timelines and key deliverables; focus on management of ail external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).
- Participate as a member of the multi-disciplinary trial{s) team.
- Develop relationships with investigational sites and institutions to enhance conduct of the trial.
- Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
- Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality ofthe functioning ofthe Development Operations Department.
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research experience.
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Prior experience in assisting the conduct and management of multinational clinical trials is preferred.
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締切: 10-01-2026
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