Site Activation (SSU) Specialist

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary ・Responsible for activities related to study start up（SSU) and ongoing study document management ・Act as point of contact for local study teams and external stakeholders Key Responsibilities ・Independently manages multiple country, study and site level deliverables during start-up and maintenance both within internal and external business partners and vendors, when required. ・Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial　milestones. ・Ensure Investigator Sites are eligible to conduct clinical trials, through the review and approval of essential clinical trial and regulatory documents. ・Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission. ・Prepare and perform submissions for Ethics Committees/IRB including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). ・Collaborates with other internal roles in country feasibility and site selection. ・Collaborates directly with the internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines. ・Prepare country Informed Consent Form (ICF) and manage country ICF template. ・Review and approval of Site ICFs ・Complete Clinical Trial Package (CTP) documentation. ・Update national registries as applicable. ・Ensures that the electronic Trial Master File 　(eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site 　activation and ongoing study management. ・When applicable, conduct drug/IMP label review & translation. ・Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal. ・May support the collection and distribution of documents from/to sites including obtaining insurance certificates. ・May support Health Authority inspection and pre-inspection activities. ・May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.

■職務概要 Site Activation Managerとして試験開始から医療機関での被験者登録開始まで、Start-up phaseの申請業務からサイトアクティベーションまでをマネジメントします。顧客および社内他部門と協業する際の窓口としても機能し、Site Start-upチーム（Clinicalも含む）をリードします。 ■職務詳細 ・合意されたサイトアクチベーション戦略に従い、プロジェクトのタイムラインを遵守しながら、担当プロジェクトのサイトアクチベーションの実行を管理監督する ・プロジェクトのScope of Workや戦略に従いマネジメントプランを策定、維持する ・依頼者・弊社 Globalチームと協業し、初回申請、契約締結、SRtEに向けた各種プロセスを策定する。 ・担当プロジェクトにおける施設費用の予算上限の確認、策定。 ・初回申請関連文書の各種テンプレート作成、維持。 ・（必要な場合）費用を含む各種資料のレビュー、承認。 ・RSUに割り当てられた予算の管理・調整 ・各部門（薬事、法務、CO、PM、SiteID等）やスポンサーと協力してStart-up phase特有の状況や成果物について検討、対応を行う。 ・部門内および他部門との協力によるプロセス改善活動を促進する。 ・必要に応じ経験の浅いメンバーのメンター、コーチを担う。 ・社内システム（CTMS、SAWF）、データベース、トラッキングツール等について完全な状態を維持する。 ・必要に応じ、顧客や社内チームに対しプレゼンテーションやトレーニングを実施する