Associate Director, Site Management & Monitoring

日本での臨床試験を主導し、実施する可能性のあるスタッフの能力を開発

仕事内容

Accountable for delivering the committed part of all clinical studies in Japan within their supervision according to agreed resources, budget and timelines complying with Procedural Documents,
international guidelines such as ICH-GCP as well as Japan PMDA regulations.
Responsible for developing staff capabilities to achieve high level of performance and productivity with the potential to lead and deliver studies in Japan

■ Accountabilities/ Responsibilities
・Ensure study deliveries within agreed timelines, cost/resources and appropriate quality in terms of site management & monitoring perspectives
・Contribute to continuous improvement activities, including study processes and other procedures
・Ensure effective clinical and operational feasibility assessments of sites level to execute study deliveries
・Ensure quality of selection of investigators, sites and SMOs (if needed)
・Ensure subject recruitment strategy including risk management of site management and monitoring areas is performed for every clinical trial and contingency plans are in place
・Ensure necessary actions are taken as a result of audits and regulatory inspections
・Ensure contribution for regulatory inspections of site management & monitoring areas
・Ensure the sharing of experiences and best/bad practices in activities related to managing sites and delivery of clinical trials from site management and monitoring perspective
・As a member of the Clinical Operations Leadership Team to contribute to the effective execution and implementation of the Japan Clinical Operations and R&D strategy
・Demonstrate accountability on the quality of deliverables from job holder’s function, by confirming the process and communicating with their staffs regularly and proactively to
identify the issues and potential risks that may jeopardize the quality of the deliverables, and take necessary actions (e.g. review the contents, training of the staffs and solving process issues etc.) in timely manner
・Develop staff within the group to lead and deliver reliable, cost-effective and high quality clinical trial data, optimising processes from operational site level study feasibilities through to study closures
・Conduct Performance and Talent Management (in line with HR plans), in order to attract, develop and retain the best personnel (talent base)
・Compliance with Procedural Documents, international and local guidelines such as ICH/GCP and J-GCP
・Perform regular co-monitoring/accompanied site visits in order to ensure staff skills and knowledge
・Model behaviours that foster preferred work environment, including adherence to Code of Conduct
・Plan and manage workload of staffs, ensuring appropriate supply of resources, including use of contract staffs
・FTE capacity planning and monitor and control workload of staffs in the group in accordance with appropriate SHE and Compliance standards Job Description

応募条件

【必須事項】

・University degree (or equivalent), preferably in biological sciences or discipline associated with clinical research

Required experiences
・Experience in working within clinical development
・Experience in overall clinical development including monitoring activities, study leadership and project management
・Capability to engage in discussions with internal and external stakeholders on scientific and practical aspects of the Study Design Concept/Clinical Study Protocol
・Basic knowledge and experience of quality management
・Experience in training and development

Skills and Capabilities
・Effective in leading, motivating and empowering others in order to accomplish individual and team objectives
・Good working knowledge of ICH GCP/ SOPs and Japan PMDA regulations
・Effective language (Japan & English) skills
・Communication skills
・Presentation skills
・Coaching skills
・Problem solving skills
・Project management skills
・Fiscal and financial awareness
・Consistently exhibits at target level 2 for Leadership capability
・Drives Performance
・Develops People and Organization
・Works Collaboratively

【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

6ヶ月

勤務地

在宅可、大阪、東京

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

フレックスタイム制度あり　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

完全週休2日制(土・日)、祝日、年末年始(6日)、年間休日125日、年次有給休暇(初年度は入社日に応じて変わりますが、次年度からは1月1日で20日間が毎年付与されます。)、慶弔・赴任・リフレッシュ、頭痛休暇ほか

年収・給与

年収　　800万円～1500万円　経験により応相談

諸手当

住宅手当、通勤手当、単身赴任手当、休日手当ほか

昇給

年１回

賞与

年間標準6ヶ月

採用人数

1名　

待遇・福利厚生

【待遇】

社宅制度、厚生年金基金、退職年金、財形貯蓄、融資制度、持株会制度、各種社会保険、リスクベネフィット（特別弔慰金、入院見舞金及び治療給付金、災害補償）、ほか慶弔見舞金マルティプル・エンプロイメントシステム、ストックボーナス

【福利厚生】

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