Clinical Team Lead

3ヶ月前


Osaka 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.

Responsible for clinical project delivery with regards to agreed time, scope, cost and quality. Key clinical deliverables include but are not limited to:

  • • Patient recruitment and retention
  • • Ensuring the clinical project team is resourced effectively
  • • Agile management of the Monitoring Visit Strategy
  • • Management of SDV burden
  • • Clinical vendor delivery
  • • Management of clinical deliverables related to protocol endpoints

Responsible for leading clinical deliverables across the following functions:

  • • Clinical Team Leads
  • • Clinical Research Associates (CRA) Inhouse CRAs
  • • GSDM Clinical Functions
  • • TMF Delivery Center
  • • Clinical and Ancillary Supplies Services
  • • Regulatory Affairs (post initial approval)
  • • Local Site Start-Up Operations (post initial approval)

Support/Lead Clinical project team ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.

Serve as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate.

Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.

Proactively identify and resolve conflicts as needed.

Understand the clinical project delivery strategy, costing assumptions and resulting budget for assigned project(s).

Monitor clinical project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets.

Proactively lead both quality control and risk assurance activities to ensure clinical project deliverables are met according to regulatory, Covance and client requirements.

Ensure successful creation and implementation of required clinical project plans. Monitor progress and manage variance to required clinical project plans and revise as necessary per SOPs.

Track and maintain key clinical project performance indicators for specified client and internal metrics. Drive successful clinical team delivery on these KPIs/metrics.

Define and manage clinical project resource needs and establish succession plans for key resources.

Perform other duties as required by the Department or Project Team

In collaboration with relevant departments, prepare and deliver presentations for new business as required.

Trains & mentors CRAs and IHCRAs in multiple areas of expertise.

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.