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Updated 2024-05-14
Activated 2024-05-14

Clinical Project Lead

  • Recruiter
  • Manager Level
This posting is managed by: Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name Company is not publicly visible
Job Type
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description *

This position will be responsible for managing assigned clinical studies globally and locally, overseeing study activities, budgets, timelines, and vendor relationships.
*

The role involves leading a multifunctional team, ensuring adherence to regulatory requirements, managing study budgets and timelines, overseeing vendors, and maintaining effective communication with stakeholders.


Description

Project Leadership: Lead a multifunctional team through clinical study activities, ensuring compliance with ICH/GCP and SOP requirements for 1-3 studies.

Study Management: Manage all aspects of clinical studies from planning to closure, ensuring adherence to goals, timelines, budgets, and regulatory requirements.

Communication and Accountability: Explain study plans, resources, and budgets to the company decision-making body, serving as the point of contact for key vendors and stakeholders.

Team Oversight: Oversee the performance of study team members, providing operational direction, and managing study-related vendors, including Contract Research Organizations (CROs) and contract labs.

Budget and Timeline Management: Develop and manage study budgets and timelines, tracking overall spend and assessing project risks. Facilitate forums with the study team to establish risk mitigation plans.

Documentation and Compliance: Ensure the development and implementation of study plans, review protocol deviations and data listings, and manage investigational products, drugs, and devices. Assist in developing internal SOPs and processes for ongoing compliance and inspection readiness.

Collaboration and Communication: Work cross-functionally to facilitate effective communication within/across internal study teams and with external partners.


Profile

* Biotechnology/pharmaceutical industry background

* Strong clinical project management experience

* Leadership skills and ability to manage global clinical studies

* Regulatory understanding and compliance expertise

* Proven track record in leading multifunctional teams

* Fluency in English and Japanese


Job Offer

* Competitive Compensation: A competitive salary package commensurate with experience and industry standards.

* Benefits Package: Comprehensive benefits package, including health insurance, dental coverage, and other wellness incentives.

* Career Advancement Opportunities: Opportunities for professional growth and development within a dynamic and innovative biotechnology company.

* Cutting-edge Projects: Engage in groundbreaking projects focused on developing precision, cell-targeting investigational therapies with the potential to make a significant impact in cancer treatment.

* Global Impact: Be part of a company dedicated to eliminating cancer, contributing to a meaningful mission with the potential to improve the lives of cancer patients globally.

* Collaborative Environment: Work in a collaborative and cross-functional environment, fostering teamwork and the exchange of ideas.

* Professional Development: Access to ongoing training and development programs to enhance skills and stay current with industry trends.

* Work-Life Balance: Emphasis on maintaining a healthy work-life balance to support overall well-being.

* Innovative Culture: Join a company at the forefront of innovation, actively involved in advancing novel anticancer therapies.

* Global Presence: Opportunity to work with a global biotechnology company with a significant presence in the United States and international markets.

* Supportive Leadership: Work under supportive leadership that values the contributions of each team member and encourages initiative and creativity.

* Employee Recognition: Recognition programs to acknowledge and reward outstanding contributions and achievements.




Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info Our client is a global biotechnology company headquartered in the United States which is responsible for developing precision, cell-targeting investigational therapies.

The company is dedicated to its mission of eliminating cancer and envisions a society where cancer patients can lead fulfilling lives.

Our client is actively involved in clinical studies, with a focus on advancing novel cutting-edge anticancer therapies into registration studies and commercialization. The portfolio includes innovative products with unique pharmacological activity, and they aim to make a broad impact in the field of cancer treatment.
Working Hours Monday - Friday
09:00 - 17:00
English Level Fluent (TOEIC 865-)
Japanese Level Fluent(JLPT Level 1 or N1)
Salary JPY - Japanese Yen JPY 10000K - JPY 15000K   
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