|部署・役職名||SSU ＆ Regulatory Specialist II~Sr l 外資グローバルCRO | 東京/大阪勤務|
Performs assigned activities within the country that lead to start－up of investigative sites in all phases of clinical trials. Responsible for delivery, with moderate oversight from the SSU Country Manager and specialist knowledge in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and reviews of essential documents required for site initiation. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start－up process on assigned studies. May act as main contact with Regulatory Authorities （RA） and Central/Regional Ethics Committees （ECs）. Under the direction and some level of supervision of the Project Lead （PL） or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PL/SSUL at the project level and line manager for deliverables. At a project level, may act as SSUL for local studies. May provide support as the Country Start－Up Advisor （CSA）.
• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures （SOPs） and Work Instructions （WI） in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start－Up （SSU） components at the country level where assigned （submissions, essential document collection, communication to Competent Authorities and ECs, etc.）.
• Ensure all relevant documents are submitted to the Trial Master File （TMF） as per Company SOP/Sponsor requirements.
Responsible for one or more of the following functions at the country level:
• Local Submissions Specialist － Follows the project direction provided by the designated country start－up advisor （CSA） and SSUL. May serve as a point of contact for the PM/SSUL （or designee） during start－up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
• Country Start－Up Advisor － Acts as Subject Matter Advisor for in－country performance within the Site Start－Up. Supports country－level intelligence on start－up （SU） and clinical trial regulatory （CTR）. Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start－up group to adapt to local requirements. This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level.
• Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• Local Investigator Contract and Budget Negotiator – Provides support to SSUL to agree on country template contract and budget. Produces site－specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
【必須（MUST）】<QUALIFICATION ＆ REQUIREMENTS>
• Bachelor’s Degree,
• Detailed understanding of clinical trial process across Phases II－IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start－up processes.
• Ability to manage external vendors to contract effectively.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Ability to manage multiple project budgets with increased complexity and value.
• Quality－driven in all managed activities.
• Good negotiating skills.
• Good problem－solving skills.