Clinical Project Manager or Specialist

製薬企業にてグローバルチームと協力してCROを通じて臨床開発を実施

仕事内容

1 Acting as the primary point of contact for the operational execution of assigned clinical Phase I-IV.
2. Delivery of study through oversight of chosen CRO(s) and interface with internal resources for appropriate facets of the operational execution and delivery.
3. Oversight of day to day operational activities of clinical projects.
4. Ownership of study risk management plan including timely communication of study progress, risks and risk mitigation strategy to Program Leadership.
5. Tracking study progress against the study schedule as detailed in Program Plans.
6. Assist Clinical Operations Program Lead with managing study costs against actual budget and providing budget forecast data as requested
7. Contribution to and review of key clinical documents, in close collaboration with other line functions (e.g.
Regulatory Affairs, Clinical Supplies, Clinical Research, Pharmacovigilance)
8. Providing input to the preparation of regulatory authority submission documents, e.g. IND, CTA, ANDA,
MAA and supporting regulatory defense activities as required.
9. Assisting regulatory with acquiring essential documents required for continual and current IND updates.
10. Responsible for filing and maintenance of Study/Project documents, specifically, but not limited to the Trial
Master File (TMF).
11. Assist with the tracking study status to study assigned Key Performance Indicators (KPIs).
12. Assist with the organization of governance type lessons learned as requested.
13. Organizing, inputting and maintaining all study related public disclosures.
14. Perform other duties as assigned.

応募条件

【必須事項】

EDUCATION/EXPERIENCE：
・Minimum of a Bachelor’s Degree in a Scientific Discipline or equivalent and 1 year experience in a clinical project management field within the Pharmaceutical or CRO industry.

LANGUAGE SKILLS：
・Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive
reports and detailed business correspondence. Ability to work with managers or directors and communicate
ambiguous concepts. Ability to present to groups across the organization in both Japanese and English.

SKILLS AND ABILITIES
・Requires strong understanding of the drug development process
ICH GCP Practitioner and working knowledge of other associated regulations, guidelines and industry standards for clinical trials ・Comprehensive operational experience in clinical research:
・Experience of Monitoring Clinical Studies
・Experience of vendor / CRO Management
・Experience in managing schedules, budget, risk and processes with a clinical trial setting.
・Proficient in PC applications (Excel, Microsoft Word, etc.).
・Good organization skills, attention to detail, ability to work as part of a global team and the ability to manage multiple tasks is required.
・Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.
・Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
・Demonstrated strong communication, influencing and interpersonal skills.
・Ability to read and interpret comprehensive and intricate research documents.
・Ability to write scientific reports and technical correspondence.
・Ability to work with executives and communicate abstract concepts.
・Ability to present to a high level of the organization and groups outside of the organization.

・Experience of operating within Global, Multidisciplinary Team
・Reliable, proactive team player with a proven track record for delivery
・Experience of operational delivery within multiple Disease areas.
・Knowledge of medical terminology

【歓迎経験】

【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

3ヶ月

勤務地

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

フレックスあり　コアタイムなし

休憩時間

60分

時間外労働

有

勤務開始日

応相談

休日休暇

■休日休暇■ 土・日（完全週休2日制）、祝日 年末年始（7日）、夏期休暇（3日） 年次有給休暇（初年度4～11日、次年度11日、最高20日） 病気休暇（初年度1～5日、次年度以降6日） 年間休日124日(2016年)/120日（2017年）

年収・給与

経験により応相談

諸手当

通勤交通費全額支給

昇給

給与改定　年1回

賞与

業績賞与（※当社規定により決定）3月に支給

採用人数

若干名

待遇・福利厚生

【待遇】

退職金制度（確定給付＋確定拠出） 育児・介護休職制度 福利厚生「ベネフィット・ステーション」加入

【福利厚生】

選考プロセス

１）書類選考
２）一次面接
３）最終面接