Chuo City
TOK Fortrea Japan kk (Co., Ltd. in English)Full time
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview:
A key operational role within our matrix organization, accountable for the clinical operational activities and performance within an assigned group of countries or delivery team, with responsibilities for customer connections and commercial activity. Leading a team with overall accountability for quality oversight & management, resource management & assurance of supply, productivity, utilization & financial delivery, talent retention & development. Maintaining a network of country ambassadors with country expertise to drive strategic country growth, representing the company both internally and externally to customers, sites, and regulatory bodies.
1-10 Countries
Medium to high complexity country(ies)
High regional & local customer connections
10-15 Direct reports
> 350 Indirect reports
Summary of Responsibilities:
Leadership
Effective leader in a matrix organization and demonstrates ability to create a network of internal stakeholders, influence peers and other departments
Effectively lead in a complex environment, set clear expectations, coach, and mentor for success, consistently communicate, and connect
Leads by example in building and sustaining a scalable organization; creates a forward looking culture of ownership and accountability; delegates for development and growth; identifies and sets up high performers for success; fosters a continuous learning environment
Partnering closely with Clinical Delivery Center of Excellence (CoE) and Project Delivery (PD), Customers and other functions driving the organization towards internal, customer and project established goals
An inspiring leader that attracts, selects, on-boards, develops and retains high performing talent; strengthens and deepens talent bench and succession planning
Provides mentorship to more junior colleagues to nurture professional growth of the Clinical Network team
Represent Fortrea Leadership to external parties and customers within the country(ies) of responsibility and region
Lead country and regional initiatives and participate in global initiatives
May act as back-up for the next level management duties
Operational Excellence
Accountable for country expertise network proactively providing clinical expertise and insight within assigned country(ies), to advise on regulatory requirements and clinical landscape to ensure most effective and efficient delivery of global projects and services
Partner with Clinical Delivery CoE peers to deliver to customer and /or project team specifications; within or below budget, on time while ensuring the highest level of quality
Participate in internal project management review and customer calls/meetings, and liaise with equivalent colleagues in other functions, to ensure support to project and customer delivery
Define strategies with the global regulatory group and the project management teams in managing local regulatory matters, acting as point of contact for local regulatory authorities
Uses established operational, financial and quality metrics and reporting dashboards to assess overall country(ies) health and proactively take action where necessary
Define and implement short-term and long-term strategies to improve operational efficiency, quality and productivity across assigned country(ies) through Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs)
Define and drive department resourcing and development strategy with assurance of supply to Clinical Delivery CoE teams, ensuring the right level talent are assigned to the right project and/or customers at the right time; ensure that the talent is fully utilized
Hold employees within the area of responsibility accountable for compliance to applicable productivity, company, and customer KPI's, quality metrics and/or dashboard objectives, customer contract terms
Partner to develop and drive the use of standardized processes and tools in alignment with associated policies and delivery practices to ensure quality, efficiency, and productivity
Accountable for selection, training, development, and performance management of employees in assigned country(ies)
Accountable for developing high performing employees, ensuring employee and teams meet, core role, project and customer delivery directives and standards
Accountable for Line Manager performance in assigned country(ies)
Accountable for resource strategy and management aligning employee volume, competency, and experience to current and projected work demand for assigned country(ies)
Develop and actively manage country specific hiring and retention plans aligned to companywide strategies and Clinical Delivery CoE requirements
Identify, lead and participate in training, onboarding or talent development strategies for the Clinical Network, partnering with other functions HR, legal, Recruitment, Training, Delivery CoE
Partner with Clinical Delivery CoE leads, other internal and external stakeholders, evaluation of quality risk trends to identify role and/or customer specific training needs
Responsible for development and management of employee competency , facilitated career paths and proactive succession planning
Ensure high level of employee engagement by addressing employee engagement survey results with implementing appropriate and effective mitigation strategies
Responsible for appropriate management and resolution of performance issues and trends in assigned country(ies)
Mobilize, motivate, and engage employees, encourage mutual support, and drive adoption of company culture standards
Quality:- 10%
Ensure that assigned employee works to highest quality standards in compliance with current SOPs, relevant guidelines/policies, training compliance, regulatory and role requirements
Proactively work to identify quality risks, partnering with all stakeholders for early intervention and mitigation, continually raising the quality standards in assigned country(ies)
Accountable for oversight and management of KQIs, identifying quality risk trends and implementing risk mitigation plans in assigned countries and supporting global initiatives
Accountable for team compliance with KQIs, monitoring quality standards and monitoring Quality Control process in assigned countries
Accountable for the development and execution of country quality plans aligned to identified quality risks
Lead and provide input to relevant SOPs and standard plans/templates
Accountable for compliance with QMS issue reporting and management
Responsible for CAPA development and management at the country level and development of country/regional/global mitigation and effectiveness checks
Budget & Finance – 30%
Accountable for resource and utilization management, budget spend and delivery aligned to project scope and profitability goals in assigned countries
Drive maximization of the profitability of operation in assigned country(ies) and/or clusters ensuring quality benchmarks and deliverables are met on time
Lead, and manage strategies to optimize financial performance and volume in assigned country(ies). Influence and explain the overall productivity and profitability of the functional business units
Proactively identify and manage cost overruns, including headcount growth. Propose and agree with relevant Clinical Delivery CoE leads strategies for delivering savings or remedies for issues observed in assigned countries
Responsible and accountable for billable hours and associated utilization in the area of responsibility for assigned country(ies). Escalate outliers, provide recommendations, and take necessarily actions assisting the management team with mitigations
Accountable for expense management and Non Billable spend, including line manager span of control and Non Billable/Billable ratio aligned to company goals
Commercial & Growth – 30%
Responsible for identifying business opportunities within country, through proactive networking with customer stakeholders
Proactively partner with BD, SDG and Operation Delivery leads to identify and support local and regional opportunities to grow the business in assigned country(ies) and/or region
Actively network and share business development opportunity information with other Fortrea functions
Provide country expertise to proactively drive strategic growth in assigned country(ies)
Support RFI response, proposal development and/or bid-defense meetings as an expert of their country or cluster of countries, or Clinical Network organization with minimal supervision
Represent main point of contact for local or regional customers
Support Contracts & Legal Budget for statutory document preparation and signature as needed
All other duties as needed or assigned
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
Qualifications (Minimum Required):
Education level: University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technician)
Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Expert level of English and local language required; speaking, writing, reading
Thorough knowledge of drug development process
Thorough knowledge of relevant SOPs, ICH and GCP guidelines
Ability to manage a team to ICH GCP/FDA/ISO14155 standards, including an understanding of local and regional regulatory requirements
Demonstrated ability to lead by example and to encourage team member to be responsible and accountable for their conduct and performance
Excellent planning and organizational skills
Demonstrated ability to successfully manage multiple competing priorities
Excellent communication, presentation and negotiation skills and ability to conduct and lead meetings
Demonstrated ability to proactively identify and mitigate delivery and customer satisfaction risks
Demonstrated ability to effectively communicate and deliver to customer needs
Ability to work in a team under time and resource constraints
Ability to work independently with minimal supervision
Strong financial acumen
Experience (Minimum Required):
Minimum of 10 (ten) years supervisory experience, including 2 (two) years of managing managers, and 1 (one) year leading a team or function with 4 (four) years experience of effectively managing customer relationship in a healthcare or clinical research setting.
Working knowledge and understanding of resource management, tools, and team development
Knowledge of human resource and employee performance management process
Preferred Qualifications Include:
Education level: Masters or other advanced degree from an appropriately accredited institution
Physical Demands / Work Environment:
Ability to drive and have a valid driver's license as appropriate per country travel standards
20-30% travel by plane, rail and car as required with overnight stays within country/region and global
Office based or home-based environment: Fortrea office presence expected where required
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
Description 【募集の背景 / Purpose & Scope】 Responsible for providing bioinformatics expertise to drug target selection, translational research, patient selection strategy and clinical biomarker analysis for multiple drug discovery and development programs. Develop bioinformatics analy ...
Chuo City
TOK Fortrea Japan kk (Co., Ltd. in English)Full time
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
Chuo City
TOK Fortrea Japan kk (Co., Ltd. in English)Full time
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
Established in 2023, but with a combined heritage of over 100 years, Envalior is entering the market as a leading global engineering materials powerhouse offering novel and innovative solutions to today's world. Envalior brings together two highly complementary established player ...
Date Posted: · Country: · Japan Location: · East Japan Region Office: Tokyo Sumitomo Twin Building East 13F, Shinkawa, Chuo-ku, Tokyo, JAPAN 役職名 · 仕事内容 · オーチスで働きませんか?オーチスには、コラボレーション・イノベーション・エンパワーメントを重視し、「人」と「会社」の成長に向けて取り組む環境があります。 · 高層ビル・マンションや商業施設等に設置されるエレベーター、エスカレーター等昇 ...
Chuo City
TOK Fortrea Japan kk (Co., Ltd. in English)Full time
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
Description · : Business Overview · Payment systems using credit cards, e-money, the Web, and apps are no longer inseparable from our lives. Rakuten Card has been the industry's top class with more than 25 million members, the No.1 credit card handling volume in Japan(based on ...
CIC is looking for a highly skilled and independent individual to take on the role of General Manager at our new Japanese campus in Fukuoka. Read further if you thrive on challenges and are excited about founding, cultivating, and connecting with the local innovation scene. ABOUT ...
Mercer is seeking candidates for the following position based in the Fukuoka, Japan office. · アカウントマネジャー · 福岡オフィス(福岡県福岡市博多区綱場町2番1号 博多FDビジネスセンター5階)※九州地域のビジネス拡大を目指し 2023å1 ́9月に開設した、新オフィス · What can you expect? · 組織人事領域に強みを持つコンサルティングファーム、マーサーのアカウントマネージャーとして、クライアントとのリレーションシップ構築、各種サービ ...
JP-
Yaruki Switch Group (Kids Duo / WinBe / Kids Duo International)Full time
Requirements · English: Native level · Japanese: None · Visa sponsorship available · Description · Kids Duo Omoto school in Okoyama Prefecture is currently looking for passionate and enthusiastic teachers to join our team · ■ What We Offer · • Starting monthly salary of ¥250,000 ...
