Clinical Trial Associate(臨床開発担当者/スタディマネージャー)

募集要項

仕事内容

・Supports the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
・Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders.
・Participates in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors and data.
・Participates in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
・Participates in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
・Participates in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
・Ensures quality and completeness of TMF 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）
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　　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