Clinical Site Manager II（臨床開発モニター/ Site Monitor/ CRA）

募集要項

仕事内容

Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits.
• Attends/participates in investigator meetings as needed.
• May serve as Regional Sub-/Lead or Global Sub-lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
• Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
• Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Ensures site non-IMP study supplies are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
• Oversees the appropriate destruction of clinical supplies.
• Ensures site staff complete data entry and resolve queries within expected timelines.
• Ensures validity and completeness of data collected at trial sites.
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
• Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
• Prepares trial sites for close out, conduct final close out visit.
• Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
• May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
• May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols, site activity and required role in CSM group. Responsible for managing own travel budget within guidelines.
• Oversight the daily activities of junior CSMs. If necessary, communicate with relevant stakeholders and try to find the new approach to avoid any obstacles.

応募条件

【必須事項】

・BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience.
・Five years site monitoring and/or site management experience.
・A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
・Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
・Strong critical thinking and problem solving skills.
・Strong IT skills in appropriate software and company systems.
・Willingness to travel up to 40% with overnight stay away from home.
・Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.
・Good written and oral communication.

【歓迎経験】

・Experience working cross-functionally and in matrix teams
・Experience in executing Lead CSM role
・Experience mentoring more junior site monitors or site managers
・Experience working in early development studies

【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

試用期間原則なし

勤務地

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）
8:45～17:45（月～木）、8:45～16:00（金）、専門業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす

勤務開始日

応相談

休日休暇

完全週休2日制
年間有給休暇：　
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：夏季休暇、年末年始休暇
その他休暇：祝日、5月1日　育児休業制度

年収・給与

年収　　600万円～　経験により応相談

諸手当

裁量労働手当、住宅手当、通勤手当　等

昇給

あり

賞与

あり

採用人数

若干名

待遇・福利厚生

通勤手当：有
寮・社宅：有
住宅手当：有

各種制度

雇用保険：有
労災保険：有
厚生年金：有

選考プロセス

１）書類選考
２）一次面接
３）最終面接