過去の求人

Senior GSPV Associate

• JPY 5,000,000 - 8,000,000（JPY5,000,000 - 8,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top 10 global healthcare company Job Description Sr GSPV Associate | Japan This position is responsible for the processing and review of AE/SAE information received from sites for completeness and regulatory compliance. Process adverse event reports received from sites/reporters. Perform QC review of completed individual and periodic safety reports. Complete data entry including writing of adverse event narrative and provide preliminary assessment of event seriousness and expectedness/listedness as per applicable Reference Safety Information. Generate adverse event queries, liaise with the medical reviewers/client to agree upon the queries, and send request for additional information to the sites/reporter. Engage with the Site Monitors to ensure follow up information is obtained from site effectively. Foster constructive and professional working relationships with all project team members, internal and external. File documents according to project specific requirements (electronically or in hard copy as applicable). Ensure case files are compliant with SOPs. Distribute safety data reports to other Sr. Safety Associate peer and Medical Monitor for review. Distribute safety data reports to clients and other relevant parties. Responsible for ensuring project deliverables are completed on time and with high quality. Ensure compliance with company policies, procedures, and standards. Participate in the development of safety SOPs and Operating Guides. Participate in project meetings. Participate in audits as required/appropriate. Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects. Lead in the development of case management related SOPs and Operating Guides. Assist with preparation/compilation, and review of safety aggregate reports. May be responsible for distributing and monitoring team workload. Provide support for Safety Lead with miscellaneous project tasks related to case management. Mentor and train other associates on processes regarding case processing. Perform literature review as appropriate for Post-Marketing cases. Communicate with other departments and clients as directed by project lead to ensure compliance with safety and PV SOP’s. Maintain knowledge of all applicable guidelines and regulations relating to safety and PV reporting. May have direct reports. Any other duties as assigned by manger. Requirements Bachelors Degree, preferably in a life science, nursing, pharmacy and five years of relevant with three years of safety/PV experience Relevant experience could include data management, CRA, clinical practice, regulatory authority, or study coordinator experience In lieu of degree or Healthcare Professional license/certification, a total of six years safety/PV experience may be considered. Familiarity with safety database systems: Argus preferred Ability to successfully prioritize and work on multiple tasks Excellent team player and attention to detail Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. Excellent knowledge of ICH guidelines and regulations relating to safety reporting. Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Powerpoint), email software (Outlook), diagramming/workflow software (MS Visio), and spreadsheet software (MS Excel) Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Ability to travel as necessary (less than 5%

Chemistry, Manufacturing and Control Expert

• JPY 8,000,000 - 12,000,000（JPY8,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview ■世界ランキング上位に入る米国製薬メーカー ■成長性のある多くの新薬パイプライン保有 ■福利厚生充実、安定して働ける環境 Job Description  日本市場に受け入れ可能な製剤開発が進められるよう他部署と協力してグローバルへ情報提供する。  PMDA相談：「期待される回答を得るため、どのように質問するのが適切か」を自ら考え、グローバルと協議して質問内容の同意を得る。  CTD作成：問題解決のため、グローバルと継続的に協議しながら当局の要求を反映させ、グローバルの合意を得たCTDを自身で作成する。  GMP適合性調査：承認時期および製造所におけるバリデーション実施時期を考慮して、適正なタイミングでGMP調査が行われるよう判断し、実施時期を製造部門と当局とで合意したうえで決定し、GMP適合性調査申請する。  当局対応：PMDA相談、CTD作成、GMP調査を行った結果、当局から来る照会事項に対して、何を求められているのかを判断し、グローバルへ説明、最善の回答となるように協議し、回答内容に合意を得た上で、当局へ回答する。必要性があれば当局との面談を計画する。  一変申請においては承認時期の管理を製造部門の情報に基づいて行う。  治験実施のタイミングに影響しないように治験薬供給を行うことを目的として治験薬の製造（包装）、出荷判定を行い、治験薬GMPで求められる記録を残す。  書面適合調査時に当局との対応を行う。そのために治験薬GMPで求められる資料を準備、調査に対応する。 Requirements ・英語でのコミュニケーションスキル ・新薬申請／一変申請の経験と知識がある ・化学および生物学の基礎知識 ・リーダーシップスキルがある。

Medical Advisor, Oncology (CAR-T)

• JPY 9,000,000 - 14,000,000（JPY9,000,000 - 14,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview ◆グローバルランキング5位以内 ◆ヨーロッパヘッドクオーター ◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ ◆癌領域に最先端の技術 Job Description Medical Advisor, Oncology To implement strategy and execution of the Japan Oncology Medical Affairs program(s) for assigned compound(s) and /or project(s), under the leadership of Japan head of Hematology Medical Franchise ※Reach and ask me if you are interested Requirements Education (minimum/desirable) ・ Medical Doctor - Ideally Oncologist/hematologist, preferably with SCT (Stem Cell Transplant) experience - At minimum clinical experience in Oncology/hematology or Internal medicine/ critical care. • Languages ・ Fluent oral and written Japanese and English • Experience/Professional requirement ・ ≥ 5 years of involvement in GCP clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ・ Strong management, interpersonal, communication, and problem solving skills. ・ Strong negotiation and diplomatic skills, experience with health authorities desirable. ・ Medical/scientific and operational expertise in oncology and/or hematology.

Contract Specialist

• JPY 5,400,000 - 9,500,000（JPY5,400,000 - 9,500,000)
• 日本 東京
• サービス業界（メディア/広告/コンサルタント/教育/外食/飲食/美容/娯楽/士業　他）

Company Overview International Entertainment Company Job Description Legal and Business Affairs - Contract Specialist 1. Contract-related Services - Discussing and Negotiating the terms of each contracts with companies. - Drafting and reviewing contracts - multiple contracts with one party - Promoting and enhancing awareness of rights-related issues - Sharing necessary legal-related information with HQ and other entities when necessary - Trademark search and confirmation, and necessary applications for usage 2.“360-degree Deals” (merchandising, ad appearance fees, live event investments, joint master-right deals etc) 3. Digital-related Business Requirements [Job Requirements] Desired Skills / Abilities More than 5 Years’ Experience in drafting and reviewing contracts in a corporate environment • • Experience in drafting both standard form and stand-alone contracts; reviewing documentation prepared by other party • • Knowledge of civic law and intellectual property (in particular copyrights/ trademarks) • • Knowledge of portrait rights pertaining to artists • • Excellent communication skills, a flexible approach, strong leadership ability when necessary • • Proactive experience in and ability to resolving problems • • Experience in the handling of rights content in the music and entertainment industries • • Understanding of English desired • • Law School graduate, desired but not necessary

化学試験スペシャリスト

• JPY 8,000,000 - 12,000,000（JPY8,000,000 - 12,000,000)
• 日本 名古屋
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview ■世界ランキング上位に入る米国製薬メーカー ■成長性のある多くの新薬パイプライン保有 ■福利厚生充実、安定して働ける環境 Job Description ・医薬品中間製品及び原材料の化学試験の実施とレビューを行う。 ・品質管理に関わる手順書及び記録書の作成及び改訂を行う。 ・新規機器導入の際の適格性評価を行うとともに、試験機器の定期的校正・保守点検を行う。 ・試験に関する専門技術を発揮することにより、日常業務以外の非定型試験にも対応する。 Requirements ・担当業務における品質管理手順書、規格/試験方法及びEHS手順書を理解し、教育できるレベル。 ・担当業務に使用する機器の原理を理解し、故障を未然に防ぐ、また、故障時の対応ができる能力を有する。 ・WWQC Policy & Directive, Testing Standardの内容（英語）を理解できる英語力。 ・海外とのメールによるコミュニケーション及び電話会議において、平易な情報交換ができる英語力。 ・新規導入機器に関するバリデーション計画書、報告書を作成できる知識を有する。 ・問題点に関して、改善策を立案し、解決に結びつけることができる能力。 ・大学にて化学又は微生物学を専攻し、卒業した者。 ・GMPに関し、品質管理業務を行う上で必要な知識を有する。

Clinical Vendor Relationship Manager

• JPY 8,000,000 - 14,000,000（JPY8,000,000 - 14,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top 10 global healthcare company Job Description Clinical Vendor Relationship Manager | Japan Summary: Partners with internal customers, providing subject matter expert support based on a deep understanding of current Global Good Practices (e.g.GxP: GCP, GcLP, and cGMP) and related processes for the specific services provided by vendors to the clinical research industry including, requirements and regulatory expectations with the ultimate goal of issue escalation/risk mitigation, improved quality and increased performance from vendors. Serves as the global primary point of contact for the Company project teams for discussions regarding areas of expertise. GxP vendors include any vendors governed by GCP, GcLP, or cGMP guidelines including but not limited to Central/Specialty Laboratories, Contract Manufacturing Organization (CMOs), Depots, Contract Research Organizations (CROs), eSystems (CTMS, eDC, IxRS, ePRO, eTMF, LMS, etc.), Imaging/Core Laboratories and Central Readers, and Translators. Essential Functions 1. Advises Vendor Management leadership to ensure the meeting of industry standards and expectations, and adherence to GxP and other applicable regulations including criteria for selection of vendors and responsibilities of various departments for implementing and overseeing vendors used on projects. Maintains awareness of industry best practices for relevant scopes of service including legal, ethical, and regulatory aspects. 2. Instructs Company staff regarding the selection of vendors by project. Acts as the internal advocate for selecting preferred providers. Drives training internally within the organization so the Company staff understands the relationship and the working practices between the vendor and the Company. 3. Provides study specific consultation and support with regards to vendor performance metrics and expectations including quality issue identification. Serves as an escalation point for study teams. Participates in the development and presentation of tools and templates. Conducts lesson learned. 4. Facilitates effective vendor management by ensuring study teams establish performance metrics and clear expectations with vendors and monitor the vendor’s compliance with established metrics/expectations throughout the life of the study. 5. Reviews and authorizes Quality and/or Technical Agreements between the Company and the vendor as required. Contributes in the design for RFI (Request for Information) used to gather vendor specific information. 6. Chairs quarterly meetings of global internal stakeholders to identify emerging needs and solicit feedback from the forum participants. 7. Oversees vendor compliance. Collects, collates, and assesses data to monitor performance of GxP vendors utilized by the Company based on relevant input from all responsible departments. Communicates vendor compliance and performance to relevant stakeholders and provides input to corrective and preventive action associated with quality issue resolution. Escalates issues and communicates status to all appropriate parties. 8. Maintains regular communication with vendors to ensure continued alignment and foster mutually beneficial relationships. 9. Identifies more strategic use of vendors, improved efficiencies and cost savings. Interprets current and emerging industry trends and identify scientific benefits to our Sponsor studies. Ensures alignment with broader corporate goals and objectives. 10. Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring. 11. Supports the analysis and selection of current and proposed preferred provider relationships in order to have the “best in class” vendors to support the Company. Identifies need to qualify new and existing vendors and communicate the need to the Vendor Qualification Group. 12. Responds to RFI and other queries from Sponsors where subject matter expertise applies. 13. Maintains and improves the vendor management database and associated internal webpage(s). Other Responsibilities: Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Maintains subject matter expertise through training (internal and external), reviews and/or preparation and presentation of papers, review of guidelines and regulations, etc. Note: If there are additional responsibilities that are specific to an individual employee, department, country, or other grouping, please use the Job Description Addendum Template. Requirements BA/BS degree in a scientific discipline or health care field or equivalent combined education and experience. Moderate experience in related global clinical vendor service area and project management. Strong and comprehensive knowledge of GCP, cGMP, and/or GcLP regulations and guidelines. Experience with managing and supervising multiple project schedules and deliverables. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. Ability to perform several tasks simultaneously in a dynamic environment in order to meet deadlines is essential.

Senior Manager, Quality Control

• JPY 8,000,000 - 12,000,000（JPY8,000,000 - 12,000,000)
• 日本 名古屋
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview ■世界ランキング上位に入る米国製薬メーカー ■成長性のある多くの新薬パイプライン保有 ■福利厚生充実、安定して働ける環境 Job Description 品質管理のラインマネージャーとして、医薬品中間製品、原料等の品質試験に責任を持ち、品質管理チームを運営・管理する。 ・品質管理責任者としての業務 ・分析法技術移管 ・チームの運営及び所属社員・期間雇用社員・契約社員のマネージメント ・品質管理に関わる経費及び固定資産のマネージメント ・査察時の対応 ・各種規制への適合性維持 ・部署のEHS・安全衛生への責任 Requirements ・大学にて化学又は微生物学を専攻し、卒業した者。修士課程を卒業した者が望ましい。 ・品質管理又は品質保証において品質管理に関わる業務を3年以上の経験。 ・英語の読み書き及び会話に関して、海外とのコミュニケーションに大きな支障をきたさないレベル。 ・部下を指導し、能力開発を行える能力。 ・年間計画作成・予算執行などを適切に行える予算管理スキル。 ・困難な問題を解決するために、分析、対策立案、実施する能力。 ・ICH、PICS、EU GMP、cGMP、GQPに関して必要な知識を有し、業務に応用出来る。

Epidemiologist, Sr Associate

• JPY 5,000,000 - 8,000,000（JPY5,000,000 - 8,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview ◆グローバルランキング15位以内 ◆福利厚生充実且つ、離職率も業界水準よりも低め ◆豊富なパイプラインとコンパウンドを持っており、今後もスペシャリティケア領域を中心に増 ◆フレキシビリティの高い働き方を推奨し、定年後も再雇用実績あり Job Description Epidemiologist, Sr Associate Job Purpose ・Leads and executes specific observational research projects within a product team or therapeutic area ・Contribute to observational research throughout the product commercialization process Key Activities ・Conducting research to the highest standards of the profession ・Aligning research with the product team’s medical strategies ・Participating in initiatives to improve processes/capabilities in evidence generation activities Key Activities and Skills Conduct of the sponsored observational studies: ・Develops study proposals and protocols in high quality ・Conducts high-quality observational research to support medical strategy ・Develops scientific manuscripts and presentations for a variety of audiences ・Supports post-marketing surveillance using existing databases ・Addresses regulatory and compliance requirements related to observational research ・Manages vendors with controlling contract, budget, and timeline ・Coordinates data purchase agreements Facilitation of observational research and use of real-world evidence: ・Contributes to medical strategy with observational research expertise ・Contributes to real-world data analyses to support various business needs ・Establishes processes for local observational research operations as needed ・Collaborates with relevant internal/external stakeholders ・Sets annual product-specific and personal goals ・Takes leadership in a matrix environment ・Promotes observational research awareness ・Stays abreast of the latest developments in the field of observational research and drug development to contributes to the field Requirements Basic Qualifications ・Master degree in Epidemiology or other subject with high observational research content or MD with observational research experience ・Three (3) or more years of clinical research and/or observational research experience in industry or academic settings ・Record of publications in clinical and/or observational research Preferred Qualifications ・Record of publications in clinical and/or observational research ・Experience in research to support drug development and/or pharmacovigilance in industry Required Knowledge ・Observational research methodology and applications ・Programming in SAS or other software (e.g. STATA) ・Literature search ・Drug development processes and operations ・Relevant regulations and guidelines ・Written and oral scientific communications skills ・Project management/project planning ・Native level Japanese and Business English (oral and written)

Site Quality Operations Leader

• JPY 17,000,000 - 18,500,000（JPY17,000,000 - 18,500,000)
• 日本 名古屋
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Labeling Manager

• JPY 8,000,000 - 10,000,000（JPY8,000,000 - 10,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Monitoring Group Manager

• JPY 8,000,000 - 15,000,000（JPY8,000,000 - 15,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Clinical Leader(Vaccine)

• JPY 8,000,000 - 12,000,000（JPY8,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Global Safety & Pharmacogivilance Manager

• JPY 8,000,000 - 12,000,000（JPY8,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top 5 global Clinical Research Company. Job Description Title: Manager, Global Safety & Pharmacogivilance Location: Japan Responsibilities Provide day to day managerial oversight to the Pharmacovigilance staff Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements Prepare and/or review expedited Safety Reports for submission to Regulatory Authorities Communicate with Clinical Research and clients to ensure compliance with drug safety and Pharmacovigilance SOPs Be the safety lead for projects; to include set-up, project management client liaison Mentor Safety Associates and other members of the Global Safety and Pharmacovigilance group involved in safety data processing Perform training of safety reporting requirements for other Clinical departments. Be responsible for SAE reconciliation for a study Ensure that the company is in compliance with safety reporting requirements of regulatory authorities Ensure that the company meets client expectations and requirements for safety reporting Provide regulatory consultation regarding safety reporting for investigational drugs Review serious adverse experience information received form investigative sites and assures compliance with reporting requirements Prepare/review safety section of regulatory reports, e.g. Annual Reports and Periodic Safety Update Reports Prepare SAE reporting plans Represent Global Safety and Pharmacovigilance group at project team, client and Investigator meetings Prepare documents describing the process for monitoring and reporting serious adverse experience (e.g., SOP, user manuals) Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting Coordinate with Medical Affairs, Clinical Research and Data Management for the efficient and timely review of safety information Assist Business Development for client development presentations that involve safety reporting as a potential service: provide adequate input into client proposals Act as project manager for stand-alone Safety and Pharmacovigilance projects Requirements Bachelor’s Degree in a life science or nursing; or RN diploma Six years relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience Good Verbal and written communication skills Excellent Knowledge of ICH guidelines and regulation relating to Pharmacovigilance Demonstrate working knowledge in MS Office applications Ability and willingness to travel (~20%)

Senior Manager, Endocrinology Medical Team

• JPY 8,000,000 - 14,000,000（JPY8,000,000 - 14,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Quality Assurance Manager

• JPY 7,000,000 - 12,000,000（JPY7,000,000 - 12,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top 5 global Clinical Research Organization. Job Description Manager, Quality Assurance Main Responsibilities: 1. Supervise, oversee and review audit. Generate and review audit reports. 2. Plan and provide strategies for potential visits by Regulatory Authorities. Develop program for and conduct ‘mock inspections’. Perform inspection preparation training to staff. Coordinate preparations and activities for announced inspections by Regulatory Authorities. 3. Host Sponsor audits and Regulatory Authority inspections. Assure that issues from Sponsor audits and Regulatory inspections are communicated and addressed. Communicate with senior department staff if Regulatory Agency. Respond to Sponsor audits of sites and resolves issues with Sponsor. 4. Provide consulting on quality/regulatory related issues. Maintain knowledge of regulations and ensure that department staff and operational management are aware of regulatory requirements governing the conduct of studies. 5. Assure that staff perform in line with budget, timeline, quality, and customer satisfaction. Assign local staff to projects and assists in the development of strategies for project execution, including the identification of resource issues. 6. Submit reports related to audit issues. Maintain tracking system to identify and follow-up on the Company deficiencies identified in Quality Assurance audits and track improvements in these systems as solutions are identified and implemented. 7. Participate and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, and employee counseling. Additional Responsibilities: 1. Train Company personnel on Quality Assurance related materials. 2. Manage Clinical Quality Assurance department’s SOPs and Work Instructions. 3. Participate in industry associations, community bodies and other relevant forums to help promote the Company in drug development community. 4. Participate in local and company-wide projects according to skills or talents and the needs of the entire organization. Requirements Requirements: · BA/BS degree in science, healthcare or equivalent combined education and experience. · Extensive experience within clinical research environment related to quality assurance. · Ability to act independently and pro-actively on customer management and project management. · Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.

Clinical Team Leader, CNS

• JPY 7,000,000 - 13,000,000（JPY7,000,000 - 13,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top 5 Global Clinical Research Organization. Job Description Clinical Team Leader CNS (Japan) Description Typically serves as the Lead CRA (LCRA) with full responsibilities for clinical monitoring and line management of Clinical Research Associates (CRAs). Ensures appropriate communication, regulatory documentation, and ongoing oversight. Provides support for business development. Essential Functions: Communication - Keeps project leadership apprised of team issues, seeking guidance as needed. Maintains timely and effective communication among team members and site staff. Attends Kick-Off, Quick Start, and Investigator meetings. Regulatory Documentation - Independently resolves protocol questions with the Project Manager (PM) and patient related issues with the Medical Monitor (MM). Maintains a record of all contacts with the PM or MM concerning protocol deviations and clarifications. Monitoring - Develops clinical plans and guidelines, including clinical monitoring plans. Assures compliance with monitoring intervals according to the project requirements. Typically acts as LCRA on studies. Monitoring and Oversight - Reviews the study scope of work, budget, and protocol content. Provides training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study. Leads weekly project calls with CRAs. Responsible for site assignments for CRAs. Ensures study specific training requirements are completed and documented. Provides assistance and/or co-monitoring with regional team for high enrolling or problematic sites. Collaborates with internal project team members to assure timely site initiation process. Facilitates the site selection process utilizing Quick Start methods and appropriate feasibility assessments, if applicable. Assists the PM with tracking site initiation status, including Institutional Review Board (IRB) approvals and scheduling of site initiation visits to coincide with shipment of clinical supplies. Reviews site visit reports according to Company or Sponsor requirements. Reviews Clinical Trial Management System to provide oversight and to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to contracted project scope. Requests clarifications and corrections to the visit reports, follow-up letters, and other site correspondence. May serve as subject matter expert on implementing study specific factors into the trip report. Reviews system reports to track CRF collection/entry and quality. Assists with clinical listing reviews. Business Development - Prepares and presents materials for bid defense meetings. Administrative - Provides status reports to the PM and the Sponsor on-site initiation, enrollment, visit(s) scheduled, and trip report completion. Line Manager – May be responsible for the supervision and administrative oversight of direct reports, which are most commonly CRAs. Develops training plan and assures training compliance for all direct reports. Evaluates strengths/developmental opportunities of staff members. Sets clear goals and objectives for all direct reports. Completes performance reviews and implements performance plans. Ensures CRA metrics are met. Meets regularly with direct reports to mentor them and to evaluate workload and metric compliance. Provides data for the maintenance of resourcing tools. Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions. Provides feedback to management on areas for process improvements and may participate in process improvement teams. Evaluates staff's competency to perform on-site visits independently via sign-off visits according to published requirements. Participates in interviewing, collaborates with HR/Training in assessing initial training needs, and orientates new hires into the team and function. Facilitates teamwork; influences and motivates team to accomplish goals by encouraging direct and open communication, resolving conflict, and demonstrating support to team members. Ensures required on-site CRA assessment, sign-off, and documentation occurs. Provides strong leadership to the team, encouraging engagement, innovation, and open communication, while implementing Company procedures. Requirements BA/BS degree in the science/health care field or nursing degree, or equivalent combined education and experience. Moderate independent field monitoring experience. Minimal lead monitoring or comparable supervisory experience. Extensive understanding of SOPs, Work Instructions (WI), FDA, and local regulations as well as ICH GCP guidelines, and an advanced understanding and application of applicable therapeutic standards. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), e-mail, and voicemail. Effective command of written and spoken local language, if not English, as well as English. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials strongly preferred.

CTL Line Manager

• JPY 7,000,000 - 17,000,000（JPY7,000,000 - 17,000,000)
• 日本 東京
• ヘルスケア業界（医療/診察/ライフサイエンス　他）

Company Overview Top seven global Clinical Research organization. Job Description Line Manager of 4-5 Clinical Trial Leaders. Requirements Line Management experience Deep knowledge of clinical monitoring including CTL or similar experience Fluent English proficiency

Order intake coordinator 2

• JPY 6,000,000 - 9,000,000（JPY6,000,000 - 9,000,000)
• 日本 東京
• メーカー(自動車/化学/家電/鉱物/工場　他)

Company Overview Leading Provider of Marine & Energy Solutions Job Description 1. Provision and execution of owner benefit (including owner works) 2. Internal sales management reporting and follow-up - Sales, order intake, order status, etc - For data analysis, sales tool, etc. 3. Business intelligence - Compilation of market data from different sources - Market share analysis - Development of reporting and integrated database for the business Requirements Desired Skills: - Analytical skills - Presentation and communication skills - Computer/IT skills (i.e. MS Office, SAP) - Affection with numbers - Ability to perform structured/accurate and detail oriented work - Good English and fluent Japanese - Interested in global marine market - Team player - Positive and can do attitude Education: - Bachelor level from business/technical University or equivalent Experience: (Mandatory) ・experience as international sales or planning of benefit for customer. (Optional) ・Previous data handling work is considered as advantage ・SAP experience is considered as advantage Additional Job Information If interested, please contact RGF Hr Consultant Jenny Zhong at: D: +81-3-4400-2607 | M: +81-(0)80-8109-7988 j-zhong@rgf-hragent.jp

営業（会計事務所）

• INR 1,650,000 - 2,200,000（JPY2,782,000 - 3,709,000)
• インド ノイダ
• サービス業界（メディア/広告/コンサルタント/教育/外食/飲食/美容/娯楽/士業　他）

Job Description ■業務内容 会計事務所にて、日系デスクの立ち上げ、および日系企業向けの営業を行なっていただきます。 ・日系向け営業業務　（日系企業対する営業活動/サービス・製品のプレゼンテーションの作成/日系企業向け窓口業務など） ・マーケティング業務　（日系企業の動向調査/新規進出企業に関する情報の収集/自社サービス・製品のプロモーション活動など） ・翻訳業務　（業務関連資料の日英・英日翻訳） ■必要スキル ・社会人経験3年以上 ・コミュニケーション能力 ・英語ビジネスレベル（インド人社員とのコミュニケーションおよび業務資料の翻訳が行なえる程度） ・新規部門立ち上げに興味のある方 ■望ましいスキル ・会計事務所・金融業界での就業経験

Accountant General Ledger

• JPY 5,500,000 - 6,000,000（JPY5,500,000 - 6,000,000)
• 日本 東京
• メーカー(自動車/化学/家電/鉱物/工場　他)