早期臨床開発、臨床開発、Early Development、Clinical Trial、Study manager

【募集の背景 / Purpose & Scope】

・This position will assist the Clinical Trial Lead (s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution, and close-out of assigned drug trials, which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

・This position is accountable to the clinical trial team for the support of the trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.

・Global試験のStudy manager経験と日本の治験実施施設対応の経験を求めます。

【職務の内容 / Essential Job Responsibilities】
(雇入れ直後)

・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.

(変更の範囲)

会社内での全ての業務

【就業環境に関する要件 / Specific Physical or Environmental Requirements】

・This position is based in Tokyo.

・This position is a hybrid position that allows flexible work as determined by the department or division. In addition, it has been basically recommended to work at office twice a week as team guidance.

・Because of working with global team members, joining TC in early morning and/or late evening is sometimes required.

【応募要件 / Qualifications】
<必須 / Required>

・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 / Preferred>
・Advanced Degree

【応募書類 / Application Documents】

和文履歴書(必須)・和文職務経歴書(必須)・英文レジュメ(任意)

Resumes

【選考プロセス / Selection details】

書類選考 → 1次面接 → 最終面接

※変更の可能性もございますので、予めご了承下さい。

CV screening → First interview → Final interview

• Please be advised that there might be a change in the process.

【勤務地 / Location】

(雇入れ直後)

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo

(変更の範囲)

会社の定める事業場および自宅

【勤務開始日 / Start Date】

応相談

Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration】

期間の定めなし

Not limited to specified period

【試用期間 / Probation Period】

試用期間原則なし

No probation period in principle

【給与 / Salary】

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000~100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise】

有り

【賞与 / Bonus】

有り

【諸手当 / Allowance】

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

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

8:45~17:45(Mon~Thu)、8:45~16:00(Fri)

Discretionary Work System

【休日 / Holidays】

完全週休2日制(土曜・日曜)、祝日、5月1日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave】

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare】

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【アステラス製薬 採用サイト/ Career web site】

https://re-

For more information about Astellas, please visit our career web site.

"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."