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Ldl (Oncology)

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GSK

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Location:
Japan , Akasaka

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Category:
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Contract Type:
Not provided

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Salary:

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Job Description:

Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all oncology areas (solid and blood) to the required quality standards, GSK written standards, local regulations and ICH GCP.

Job Responsibility:

  • Leads the local study team consisting of within-country clinical operations team members, cross-functional experts, vendor staff and external clinical site staff
  • Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team
  • Accountable for within-country delivery of assigned studies to time, budget and quality expectations
  • Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved
  • Accountable for the accuracy of study systems, including completeness of the trial master file
  • Identifies and resolves or escalates issues and risks that may impact study delivery
  • If needed, may provides feedback on performance, capabilities and competencies of local study members
  • Has the accountability to estimate, track and deliver against the local budget for the studies
  • As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations
  • As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority and local Ethics Committees
  • Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area
  • As required, assists with audits/inspections of local clinical operations department and study / sites
  • Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs
  • Available and willing to travel as job requires

Requirements:

  • Bachelor’s degree in life sciences, pharmacy, or a related field
  • At least 3 years of experience in clinical operations or study management
  • R&D Experience and knowledge in Oncology areas
  • Strong knowledge of GCP, ICH guidelines, and local regulatory requirements
  • Proven ability to manage complex clinical studies across multiple geographies
  • Excellent communication and leadership skills, with the ability to collaborate effectively
  • Fluency in Japanese and English (Japanese: JLPT 1 level and English: TOEIC score of 800 or above is required)
  • Master’s degree in a science-related field
  • Advanced knowledge of drug development processes and clinical trial operations
  • Ability to lead cross-functional teams and manage external partnerships

Nice to have:

  • Master’s degree in a science-related field
  • Advanced knowledge of drug development processes and clinical trial operations
  • Ability to lead cross-functional teams and manage external partnerships
What we offer:
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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