Clinical Study Lead

グローバル企業にて開発におけるスケジュール、予算も含め研究の計画から終了まで全体を管理

仕事内容

・Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements (1-3 studies).
・Manage overall aspects of clinical studies from planning study through study closure, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements.
・Accountable for explaining study plan, resource and budget to company decision body.
・Oversee performance of study team members in either a matrix management model and/or as direct reports on their management of study deliverables, and actively provide operational direction and/or general supervision.
・Develop and manage study budget and timelines with clear assumptions.
・Track overall spend for the study over the course of the study.
・Develop and manage study timelines which includes ability to assess project risks and facilitate appropriate forums with the study team to establish risk mitigation plans.
・Manage study-related vendors including CROs and contract labs.
Serve as point of contact for key vendors and stakeholders.
・Responsible for ensuring development and implementation of applicable study plans, e.g., protocols/amendments, informed consent templates, Communication/Risk Mitigation Plan, eCRF ＆ CRF forms/completion guidelines and site reference manuals/instructions.
・Manage Investigational Product, drug and device.
・Oversee Co-Monitors to ensure site and vendor compliance together with Clinical Operations.
・Review protocol deviations and data listings as needed to ensure sponsor oversight.
・Work cross-functionally to ensure appropriate communication to stakeholders within/across study teams at and with vendors.
・Review and provide input to vendor contracts, SOWs and assist with invoice reconciliation as needed.
・Assist in development of internal SOPs and processes to ensure ongoing compliance and inspection readiness.
・Attention to detail and ability to prioritize tasks to meet critical timelines.
・Able to collaborate effectively with the study team, cross-functional team members, and external partners.

応募条件

【必須事項】

・Bachelor’s degree or equivalent in the life sciences or related field
・Minimum 7 years related industry experience with international company (including CRO)
・Experience with global clinical studies
・Experience managing study timelines, vendor contracts and budgets.
・Strong leadership and, organizational and project management skills, including ability to multitask and organize/track information.
・Strong working knowledge of the drug/device development process, GCP and ICH guidelines
・Detail-oriented and proactive recognition of issues as they arise with resolution and/or appropriate escalation to management as warranted.
・Excellent interpersonal, written, and verbal communication skills in ・Japanese and English
・Ability to work independently and in a team environment.
・Strong computer skills and high level of proficiency with Microsoft Office (e.g., Word, Excel,PowerPoint, Outlook)
・Ability and willingness to travel to nationally and internationally, depending on study activities.

【歓迎経験】

・Previous experience with oncology and/or combination drug-device studies is preferred.

【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

6ヶ月

勤務地

在宅可、東京

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

みなし労働時間制
専門業務型裁量労働制

勤務開始日

応相談

休日休暇

年間休日数：125
土日祝
年間有給休暇：　10日 ～ 20日
法定休暇：年次有給休暇
特別休暇：夏季休暇、年末年始休暇

年収・給与

年収　　～1400万円　経験により応相談

諸手当

昇給

年1回

賞与

年俸制となります

採用人数

1名　

待遇・福利厚生

通勤手当：有

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）二次面接
４）最終面接