お仕事情報

お仕事情報

Site Engagement Manager:SS-4036MY

  • 外資系企業
  • 女性が活躍
  • 英語を活かす

医薬品・医療機器開発受託業務を提供するグローバル CRO です

求人コード SS-4036MY
募集職種 Site Engagement Manager
職務内容 JOB SUMMARY:
Site engagement is a critical component in the execution of a clinical trial. Engagement of highly motivated clinical investigators will enable UCB to maximize efficient and timely delivery of Client’s clinical trials. This position is responsible for contributing to an industry leading site engagement team at the Client. The Site Engagement Manager is responsible for providing operational expertise to sites through ownership/management of Site Engagement Strategy. The scope of this role includes the following:
・Define and implement strategies for engaging clinical sites and investigators
・Characterize and understand the attributes of a good clinical site versus a poor performing site
・Engage clinical sites to develop build, and maintain relationships with investigators/staff to ensure continued performance and capitalize on site expertise
・Evaluate, screen and develop high quality investigative sites to support the Client’s clinical development programs
・Ensure collaboration with key internal & external stakeholders, as well as third party vendor
・Ensure industry best practices consistent with all applicable guidelines and regulations
・Identify business improvement opportunities that overall enhance GCSO’s site engagement capabilities with the guidance of the Head of Site and Patient Solutions (SPS)

MAJOR ACCOUNTABILITIES:
As the Site Engagement Managers:
・Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Client Clinical Team and key internal stake holders throughout the life cycle of the Client clinical trials
・Support the Client clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of the Client trials
・Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of the Client and its activities thereby increasing their desire to partner with the Client
・Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to the Client forums, boards and/or discussions
・Act as point of escalation for the Client sites offering a different vantage point and conduit for communication to the Client clinical team, internal stakeholders, SPI Partners and third-party vendors
・Singlepoint of contact for institutions to resolve business process barriers.
・Assist sites with enrolment barriers by reinforcing protocol specific site recruitment plans
・Communicate regularly with global Site Engagement Team and work collaboratively to share information, insights, and experiences with team and key internal stakeholders/customers
・Support assigned studies from a regional and cultural perspective & support study teams with quality related visits as needed
・Work with strategic partners to ensure alignment on systems and processes for identifying and engaging sites
・Ensure appropriate engagement and communication with internal stakeholders regarding SPSsite visits and related activities
・Interact/train new investigators to work on the Client clinical trials
・Develop partnerships (institutions and key investigator relationships)
・Attend key therapeutic trainings/meetings and/or industry trainings

As a member of the SPS team:
・Collaborate/Communicate on regular basis with SPS Team, GCPM Clinical Team and other relevant stakeholders, including strategic partners, to ensure integration of activities and identification of areas for improvement
・Support internal SPS teams and activities, in identification of quality clinical investigative sites for current and future the Client trials
・Act as internal advisor/partner in all aspects of site engagement supporting site selection, patient engagement and patient recruitment
・Support efficient and effective communication and information exchange across all stakeholders
・Ensure that all Client SOPs are adhered to and country regulations and GCP guidelines are followed with respect to site selection and engagement
・Travel including overnight stays, possibly global, up to 50%
応募要件 EDUCATION & QUALIFICATION:
・Bachelor's Degree
・A minimum of 5 yearsof experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies)
・Proven track record of success on cross-functional projects in a global environment. Good working knowledge of GCP guidelines in different regions
勤務地 東京
年収 600万円~900万円
最終学歴 大卒
推奨される資格要件
その他 Others:
・当該ポジションが含まれるチーム構成
Site Engagement Manager(SEM)はGlobal teamに属しており、US3名、EU3名、Asia5名(日本4名韓国1名)が所属しています。加えて、US及びEUでもコントラクトSEMが活躍しています。

• 実際に当該ポジションで業務を行っているメンバーのback ground
日本のチームのメンバーは、SEMに配属される前に10年以上の医薬品開発業務の経験を持ち、オペレーションの責任者としてCROと協働しながらクライアント企業の臨床試験を円滑に推進してきました。そして、日本のチームは、MR 、看護師、薬剤師と様々なback groundを持つメンバーで構成されています。

• 職場の雰囲気
クライアント企業は中途採用の社員のみで構成された会社ですが、それぞれの経験を活かして仕事をしています。職場はオープンな雰囲気で意見交換もしやすく、他部署にも相談しやすい、積極的に業務に取り組める環境です。

• やりがい
自らベストと思われる症例エントリーに対する戦略の策定・実行並びに結果の検証、戦略に基づいたハイポテンシャルサイトの発掘、また、治験実施医療機関がいち早く症例エントリーできるよう早期に施設を立ち上げる、といった症例のリクルートメントスピードの向上を成し得た際に充実感を覚えます。また、治験実施医療機関からの問い合わせなどに迅速に対応し、クライアント企業に対して強い信頼を得ることも醍醐味です。

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