INNOVATIVE MEDICINE] R&D, LOCAL TRIAL MANAGER, ONCOLOGY CLINICAL OPERATION

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[概要] 日本国内で治験を実施するためのオペレーションチームリーダーとして、国内外のステークホルダーとの協議・交渉など、エキスパートとしてのコミュニケーションを通じ、品質を確保した臨床試験を計画通りに遂行する。 [具体的な業務例] ・試験実施施設の選定戦略、症例組み入れプラン・戦略の作成及び実行 ・試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 ・試験全体の進捗およびGCP，SOP に沿った臨床試験の実施と品質の確保 ・国際共同試験の場合、海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション ・試験におけるRisk & Issue Management ・治験契約締結交渉、データ固定、GCP・SOP に基づくモニタリングに対するモニターへのフォロー ・チームビルディング、ステークホルダーマネジメントによるチーム作り ・社内の改善活動 / Task force team への参加 ・試験全体の予算の管理 Position Summary.
The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.
The LTM II is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
The LTM II is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles.
The LTM II may have some site management responsibilities.
The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.
Qualifications ＜職務経験＞ ・治験実務あるいはモニタリング業務経験　5 年以上 ・国内臨床試験および国際共同試験の施設選定からデーターベースロックまでのモニタリング経験 ・治験の実務を通じた後輩社員の指導 ・Trial Management の経験（Study manager/Operation manager / Trial manager 等）またはモニタリングチームのリーダー経験 ＜必要とする能力・スキル＞ ・進捗管理および品質管理 ・Issue management に関する基礎知識を有し、それに基づく実務経験 ・チームマネジメント（チームビルディング） ・Global Process（FDA やEMA のRequirement，ICH GCP に則ったプロセス≒国内および海外での申請を目的とした国際共同治験）に基づく治験実務担当経験 ・英語でのコミュニケーション（電話会議，メール） ・パソコン等：Word，Excel，PowerPoint，EDC やCTMS などのシステムが使える ・日本国内の医療機関訪問を目的とした出張が可能な方（飛行機搭乗を伴う出張有） ＜資格／免許＞ ・特になし ＜学歴＞ ・医学、薬学、生物学系大学　学部卒業以上 ＜応募書類＞ ・本人用意の職務経歴書（英語・日本語の両方必要） ＜求める人物像＞ ・プロジェクトチームや組織に対して積極的に貢献すべくリーダーシップを発揮できる人。 ・業務の成果達成に対して責任をもち，常に前向きに取り組める人。 ・円滑な業務遂行のため，社内外の関係者と良好な関係を構築する意識とコミュニケーション力を持っている人。 ・グローバルとコミュニケーションし，強い協力関係を築ける人。 ＜好まれる職歴等＞ ・外資系企業でのoperation manager 経験 Principal Responsibilities.
1.
Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL.
Implements any local criteria for site selection.
Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report.
Recommends suitable sites for selection to participate in trial.
2.
Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
3.
Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs 4.
Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations.
Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.
Including but not limited to.
development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
5.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
6.
Maintains and updates trial management systems.
Uses study tools and management reports available to analyze trial progress 7.
Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
8.
May submit requests for vendor services and may support vendor selection.
9.
In certain situations, may assist in negotiation of trial site contracts and budgets.
Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget.
Adheres to finance reporting deliverables and timelines.
10.
Attends/participates in Investigator Meetings as needed.
May schedule and conduct a local/country investigator meeting 11.
Conducts local trial team meetings and provides or facilitates SM training when needed (i.
.
implementation of study amendment-and changes in study related processes).
12.
Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed 13.
Reviews and approves site and local vendor invoices as required.
Manages local study supply, as required.
14.
Prepares country specific informed consent in accordance with procedural document/templates.
Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
15.
Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements 16.
Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits 17.
Complies with relevant training requirements.
18.
Acts as subject matter expert for assigned protocols.
Develops strong therapeutic knowledge to support roles and responsibilities.
May represent GCO on cross functional teams.
19.
Acts as primary local/country contact for a trial.
Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
20.
Actively contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
21.
Conducts accompanied site visits with SM as delegated by FM.
22.
May assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
23.
May represents functional area in process initiatives as required Principal Relationships.
Primary Reporting Structure.
Reports to a Functional Manager Primary interfaces.
Functional Manager/CRM, CTAs, SMs, CTM/GTLs, Study Responsible Physicians (SRP), Quality & Compliance Managers/Specialists, Local Safety Officer Other Internal Interfaces.
R&D Country Head, Regional Therapeutic Area Experts (RTAEs), Contracts & Grants, CTM/GTL, R&D study team (e.
., SRP), data management and Medical Affairs (when applicable) External Interfaces.
Trial Site Personnel, external vendor representatives, Ethics Committee and others as required Education and Experience Requirements.
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Minimum five years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), however other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Specific therapeutic area experience may be required depending on the position.
Should have solid understanding of the drug development process including GCP and local regulatory requirements.
Willingness to travel with occasional overnight stay away from home.
Solid leadership skills.
Solid communication and computer skills required.
Proficient in speaking and writing the country language and English language.
Excellent written and oral communication skills Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred.
The ability to lead initiative/small teams.
Flexible mindset and ability to work in a fast-changing environment.
Ability to work on multiple trials in parallel.
Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).