SSU＆Regulatory Specialist（治験の施設立ち上げ）

募集要項

仕事内容

・ 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 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 startup 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 pplications. 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.

応募条件

【必須事項】

・ 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.
・ Demonstrated ability to work independently as well as part of a team

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

東京　大阪

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：120
土日祝
年間有給休暇：　10日 ～
法定休暇：年次有給休暇
特別休暇：年末年始休暇
その他休暇：疾病休暇(5日)※入社月により変動

年収・給与

年収　　600万円～700万円　

諸手当

交通費支給（上限月10万円）、出張手当、時間外勤務手当

昇給

年1回

賞与

年俸制

採用人数

1名　

待遇・福利厚生

通勤手当：有
在宅勤務（オフィス勤務、ハイブリット勤務、完全在宅勤務）、継続雇用制度(再雇用)（一部従業員利用可）、確定拠出年金制度、在宅勤務手当（在宅勤務該当者のみ支給）

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
定年：65歳

選考プロセス

１）書類選考
２）一次面接
３）適性検査
４）最終面接