転職・求人情報の詳細をご覧になる場合は会員登録（無料） が必要です
| 部署・役職名 | CTL（Clinical Trial Liaison） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the local fieldbased representative for the sponsor company in one or more countries/regions supporting clinical development programs. The CTL interacts with investigator sites and other parties related to clinical trial execution. The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both identifies and helps facilitate resolution of investigator site issues. Key accountabilities: Provides country/regional operational insight into site feasibility and selection and overall patient recruitment strategy Participates in Clinical Study Team Meetings and Quality Review Meetings where necessary providing input to study teams on operational issues based on site visits and contacts Attend and present at investigator meetings, monitor workshops Participate in site visits with investigators site staff and CRO representatives in support of clinical trial execution and report back to study teams e.g. feasibility, start-up activities, enrolment or escalated site issues Responsible for review, documentation and follow up of investigator site issues including tracking metrics Provides sponsor regional operational support and acts as point of escalation for investigator sites Participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative Contributes to process improvement initiatives when required Perform oversight monitoring on a triggered basis, as required, and produce relevant reporting and feedback Ensure compliance with SOPs (Standard Operating Procedures), GCP (Good Clinical Practice) and other relevant guidelines/processes on an ongoing basis Act as field-based reference point of scientific and clinical expertise for study sites. |
| 労働条件 |
【勤務地】 東京（クライアント本社） 【雇用条件】 正社員 ※試用期間6カ月（雇用条件変更なし） 【勤務時間】 9：00－18:00（1時間休憩）※クライアント先就業規則に準ずる 【休日・休暇】 ・土曜 ・日曜 ・祝日 ・フレキシブル休暇（年間2回に分けて取得可能、最大3日間） ・年末年始 （年間125日以上） 【待遇・福利厚生】 ・社会保険完備 ・交通費全額支給（規定あり） ・その他 |
| 応募資格 |
【必須（MUST）】 Education:Pharmacist, PhD, MSc in a relevant scientific field or associated qualification (preferred), BSc. min. requirement Fluent written and spoken English (mandatory) and local language of country to be covered 【歓迎（WANT）】 Experience:Minimum 5 years relevant experience in pharmaceutical industry MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience e.g. CRA (Clinical Research Associate) preferred, KAM (Key Account Manager) with Clinical Trial background possible Clinical trials experience and understanding of clinical trial methodology and management Experience of working within relevant therapeutic area Experience in management of KOLs, Researchers and HCPs at all levels in both 1:1 and group settings Experience of working within the relevant National Pharmaceutical Codes of practice. Skills: Communication and strong, collaborative interpersonal skills Demonstrable thirst for knowledge (technical, clinical, medical, scientific) with an ability to assimilate information quickly, present clinical data clearly and concisely and discuss the statistical and clinical relevance in line with clinical development strategy Ability to work autonomously, in a field-based setting, whilst contributing positively to the Clinical Operations Function Ability to drive performance of self and others Highest ethical, transparent standards Job Requirements: • Extensive experience in global clinical trial operations required • Experience in Oncology trials a role requirement • High travel required – International responsibility may be required, flexibility needed • Extensive medical and scientific knowledge and clinical development understanding • Excellent communicator of technical and scientific information • Excellent interpersonal skills, ability in both in-person and virtual engagement of HCP’s • Demonstrated collaborative as well as independent working style • Ability to build relations with the external medical community • Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs) • Strong organizational skills with effective use of time and prioritization. Must be able to prioritize and manage a high volume of studies – Pharmaceutical company have a very large cross-therapeutic portfolio of clinical trials being run globally • Cross cultural awareness and fluent in at least one commonly spoken European language in addition to English • A working knowledge of ICH/GCP |
| アピールポイント | 自社サービス・製品あり 女性管理職実績あり 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 完全土日休み 月平均残業時間20時間以内 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2023/02/10 |
| 求人番号 | 2593061 |
採用企業情報
- 採用企業名は会員のみ表示されます
-
- 資本金50百万円
- 会社規模101-500人
- 人材紹介・人材派遣
- その他
