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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

FSP Study Management Associate III / スタディ マネジメント アソシエイト (東京、大阪、在宅)

Job ID 73421BR Japan - Any Region - Home Based
担当試験を実施していくにあたり、関係する部門のファンクションリーダーや国内外のベンダーと連係を取りながら、品質担保、タイムラインを遵守、予算内で、試験がうまくいくようサポートする。
また、クロスファンクショナルスタディチームをリードするプロジェクトマネジャーをサポートし、メンバーにコーチングやアドバイスなども提供します。


具体的には
■クライアントリエゾン:
  社内外のステークホルダーや国内外のベンダーとの間のコミュニケーションインターフェース。

■プロジェクトプランニング/立ち上げ:
プロジェクトツール、必須文書保管、施設選定、モニタリング計画などの必要情報をメンバーに提供し、他部門のリーダーやコーディネーターと協調しながら立ち上げを推進。

■プロジェクト開始後のマネージメント/評価:
プロジェクトのライフサイクルを見据え、リソース状況を継続的にモニタリング。問題発生時は問題解決に関与。試験の各工程をモニターしながら、プロジェクトの成果物を担保。オーディット/インスペクションの準備や対応。

■プロジェクトクローズ:
データベースロックにおける支援、関係者にLesson learnedや情報を共有。

The Study Management Associate III (SMA III) is responsible for the coordination of matrixed functional areas and/or study vendors to ensure execution of the clinical studies according to timelines and budget. This position can also be part of a global project management team and acts as a role model and/or coach for the team.

Key Accountabilities:

- Client Liaison: Effectively communicate with internal and external customers as well as third party vendors
- Project Initiation & Planning: Manage study start-up activities. Provide input to project tools, PM plan, Central File Maintenance Plan. Provide input to and oversight of site selection strategy plan and monitoring plan. Establish efficient / effective working relationships with other functional Leaders and coordinators. May develop site study budgets and approve payments to sites/vendors based on contracted scope.
- Project Implementation, Control & Evaluation: Provide leadership and direction to project team members. Support evaluating and identifying resourcing needs and continuously monitor the use of resources over project life cycle. Provide input to Identifying, organizing and delivering (where appropriate) study specific training. Address identified and escalated site issues and drive to closure. Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project. Support overseeing maintenance and quality check of Central Files. Maintain and assure quality of work generated and escalate and follow up as appropriate. Prepare, participate in and follow up on audits / inspections.
- Project Close-out: Collaborate with project team on database lock activities. Ensure all administrative closeout procedures are completed according to the study plans. May participate in end of study meeting and give input to lessons learned information and feedback relevant information into the relevant functions.

Skills:

- Strong customer focus, ability to interact professionally within a client organization
- Commitment to quality work and respective consistent performance
- Ability to lead virtual teams across locations and cultures
- Carefully weigh the priority of project tasks and direct team accordingly
- Ability to proactively identify and solve problems by using a logical, systematic approach
- Ability to make decisions even in ambiguous situations to achieve project timelines and quality
- Ability to conduct root cause analysis in business problem solving and process improvement development
- Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
- Effective time management in order to meet daily metrics or team objectives
- Excellent interpersonal, oral and written communication skills
- Good presentation and consulting skills
- Ability to travel as required

Qualifications

  • Senior CRA, Senior Project Specialist, Associate Project Manager 同等の経験、スキルを有する方。(最低4年以上の臨床開発の経験要)
  • ジュニアスタッフのメンター経験や、後輩の指導した経験。
  • 英語力(読み・書き・会話)必要。
<このポジションの魅力>
  • 自分自身のキャリアの幅が広がる。

  • 製薬会社の重点開発戦略品の開発方針を理解できる。

  • スポンサーである製薬会社に近い立場でプロジェクトをリードできる。

  • CRO側とは、異なる角度から見れる。

  • 他のCROでは、まだやってない初めてのモデルである。

- Bachelor's degree or equivalent in a life science or nursing qualification. An Associate’s degree/R.N. or equivalent with relevant clinical management experience is acceptable.
- Must have 4+ years of Pharma-related/ clinical research related experience.
- Extensive understanding and experience in cross-functional activities through all aspects of project life cycle, from study initiation through study completion.
- “Coordinating experience”: Preferably obtained while working in a Sr CRA or Sr In-house CRA position
- Thorough knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations
- Proficient computer and internet skills including knowledge of MS-Office products such as Excel, Word, Power Point, Outlook, WebEx. Significant experience with relevant clinical research systems and software is strongly preferred.
- Strong command of written and spoken English language, local language proficiency as required.

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