Clinical Trial Lead

募集要項

仕事内容

（雇入れ直後）
• Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities
• Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
• Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
• Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
• Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team
• Lead feasibility assessment and selection of countries and sites for trial conduct
• Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables
• Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
• Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders
• Participates in inspection readiness activities including coordination of clinical study team deliverables
• Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
• Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy
• Facilitate and manage regional KOL interactions, as applicable
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
• Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
• Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
• Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials

応募条件

【必須事項】

・BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience.
・Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
・Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
・Requires project management skills and trial leadership ability.
・Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability.
・Fluent in English
・Moderate (~25%) travel required

【歓迎経験】

・Advanced Degree

【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）
本社：8:45～17:45（月～木）、8:45～16:00（金）

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　　700万円～　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