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Clinical Trial Leader / Biopharma

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

      Title: Clinical Trial Leader

      Location: Tokyo

      Report to: Head of SBDO Japan

      Direct report: 0 (Single contributor)

 

      Accountabilities

  • Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
  • Accountable for oversight of CROs in the execution of Phase I – III global clinical trial(s).
  • Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
  • Accountable for the successful preparation and presentation of operational content at key governance discussions
  • Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team
  • Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
  • Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
  • Accountable for partnering with CRO in audit responses and addressing quality issues.
  • Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
  • Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
  • Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
  • Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
  • Ensures strong inspection readiness application for all assigned clinical trials.
  • Manages a small project or project stream with tasks of low to moderate complexity within a larger project. Leads a small project team with members typically from direct working environment and a straightforward project structure. Coordinates stakeholders from own area or even closely related areas or is partially or even fully responsible for the project’s management within small to medium sized projects. Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
  • Accountable for projects within a clearly defined scope and milestones. Receives moderate to low level guidance and direction within broad guidelines.

 

Candidate Profile:

EducationBS/BA in life sciences/healthcare-related discipline or RN. 

Languages: Native level in Japanese and fluent in English

 

Industry Experience

  • Experience in all aspects of clinical study planning and start up (including budget and resource planning), and in executing the complete range of clinical study activities, from start up through final study report. 
  • Strong leadership competencies and influencing skills.
  • Effective oral and written communication skills
  • Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
  • Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)

 

Clinical Trial Lead

  • The candidate NEEDS to have led GLOBAL trials (either in Japan or overseas)
  • Minimum of 3 years in clinical research in a CRO, study site or Pharmaceutical/Biotechnology Industry.  At least 2 years of in-depth knowledge and experience in clinical trial management.
  • Relevant professional experience or substantial professional experience in support/services/operations. Requires some previous project management experience. Require a substantial amount of professional experience and additional qualifications that also provide exposure to project management principals and fundamental concepts.

 

JOB-SPECIFIC COMPETENCIES & SKILLS        

  • Handles, oversees and prioritizes multiple tasks simultaneously; good time management skills; works with moderate supervision; highly self-motivated and proactive.
  • Ensures studies are run according to plan and expectations, ultimately resulting in timely and high-quality delivery of projects; directs daily operations of clinical study(ies) to meet expected timelines and achieve milestones while ensuring quality and adhering to budget.  
  • Finds creative solutions to problems and make suggestions for the improvement of existing processes
  • Thinks beyond the confines of own function; considers interfaces and actively fosters cross-functional cooperation, ability to manage internal and external customers; Knows his/her customers, builds relationships and treats them with professionalism
  • Anticipates, recognizes, and manages issues: Analyzes clinical study and investigative site risks and implements corrective actions, where required. Applies critical thinking skills.
  • Collaborates with vendors and verifies each is meeting expectations according to scope of work and budget on assigned study.  Utilizes technology and available sources of data to verify vendors are on target for deliverables in an ongoing manner.

 

Recruiting contact: Fang LIU

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  220500
Location:  Tokyo
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Clinic, Neurology, Oncology, Biotech, Healthcare, Science, Research

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