募集要項
- 仕事内容
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• Trial Master File (TMF) Management
• Initiate and lead the set up of TMF including tracking of documents.
• Implement of appropriate quality check of the study-related documents in TMF and check GCP and SOP compliance.
• Check the status of document storage (Completeness, Timeliness) and share the information to study team.
• Coordination of Clinical Trial Notification (CTN)
• Set a schedule of necessary actions for CTN submission
• Coordinate information collection for CTN and draft it and manage timing of CTN update for regulatory compliance.
• JNDA/Inspection
• Prepare index/documents required submitting to Regulatory authority.
• Assist in activities associated with regulatory inspections.
• Study documents/materials Management
• Initiate and maintain production of study documents, ensuring template and version compliance (e.g. Certificate of Insurance, Personnel list and other applicable study delivery document).
• Prepare the appendices for the Protocol/Clinical Study Report.
etc.
- 応募資格
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- 必須
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• At least 2 years’ experience in pharmaceutical industries or healthcare organization.
• Demonstrates sound knowledge of GCP and procedural documents as they pertain to study delivery systems and processes.
• Consistently exhibits Leadership capability as below
• Works Collaboratively: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business.
• Commitment to Customers &Integrity: Tailors products/services based on an understanding of customer needs, acting with integrity to drive business value.
• Acts Decisively: Makes independent/effective decisions that are guided by company values.
• Works Collaboratively: Creates an environment in which diverse viewpoints are sought and encouraged
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 想定年収：600万円～800万円程度（応相談）※ご経験・スキルに応じて検討します。
- 待遇・福利厚生
- フルフレックス制度 在宅勤務制度（週2回） 社会保険完備
- 休日休暇
- 完全週休二日制（土曜、日曜、祝日）、年末年始休暇、年次有給休暇
