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Parexel
Parexel
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Parexel is a global clinical research organization serving biopharmaceutical companies throughout the development of new medicines. Its work spans Phase I–IV clinical trials, portfolio and trial management, regulatory strategy, market access, and lifecycle planning. With more than 21,000 professionals, Parexel combines clinical, regulatory, and therapeutic expertise with patient insights and innovative trial designs. The company supports research across areas including oncology, neuroscience, and rare diseases, with a focus on making clinical development more efficient and patient-centered.
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Site Activation Partner – FSP Contractor in South Korea

Coordinate clinical trial site activation activities across South Korea for Parexel’s clinical development services. Manage regulatory submissions, investigator documentation, ethics approvals, and study compliance.

KRSouth KoreaHybridFull-timeJuniorMiddleNo degree requiredEnglish RequiredAffiliate ManagerAffiliate Marketing
Google Cloud Platform

Description

  • Coordinate clinical trial site activation activities and manage essential study documents
  • Assemble Investigator Initiation Packages to support site initiation approval
  • Resolve or escalate site issues and coordinate internal support to keep activation on schedule
  • Prepare, verify, and submit regulatory materials, including IIP documents, IRB forms, and FDA 1572 or Attestation Forms
  • Support central and local ethics committee packages, submissions, communications, and approvals
  • Prepare and distribute clinical documents and reports in line with assigned scope and SOPs
  • Support Shared Investigator Platform activities aligned with Pfizer’s strategy
  • Maintain essential documents and lifecycle updates, including protocol amendments, FDA 1572 or Attestation revisions, and annual ethics committee approvals
  • Manage IRB and Ethics Committee activities and file documentation in the Trial Master File
  • Perform periodic quality checks of study files for accuracy and completeness
  • Update clinical trial systems that track site compliance and performance
  • Assist investigator sites and study teams with audit preparation and responses
  • Maintain regular communication with study teams and investigator sites and provide country- and site-level updates
  • Create tracking tools and share ethics and site approval updates with stakeholders
  • Deliver awareness sessions covering client requirements and documentation compliance
  • Identify and resolve investigator site issues and coordinate corrective and preventive actions
  • Serve as a Site Activation Partner contact or subject matter expert for systems, processes, projects, and global initiatives
  • Help mentor newly hired team members
  • Complete required training, timesheets, expense reports, and CV updates
  • Follow Parexel procedures, ICH-GCP standards, and applicable regulatory requirements

Requirements

  • At least two years of relevant clinical site management experience
  • Experience with a pharmaceutical company or CRO in study site activation is preferred
  • Working knowledge of clinical trial methodology, ICH-GCP, FDA requirements, and applicable global and local regulations
  • Understanding of clinical research and development processes and the core operational elements of clinical trials
  • Strong awareness of quality standards and right-first-time delivery
  • Ability to comply with company, regulatory, and country-specific requirements
  • Highly detail-oriented with a structured and disciplined working style
  • Able to work independently while contributing effectively as part of a team
  • Strong task, time, and priority management skills, with the ability to multitask
  • Basic knowledge of medical terminology and GCP requirements
  • Comfortable with computer operations and independently learning multiple systems
  • Proficiency with Microsoft Suite, CTMS, electronic Trial Master File and Investigator Site File systems such as Florence, document exchange portals, Shared Investigator Platform, and relevant ethics, national network, and governing-body platforms
  • Willingness to work outside standard hours when required in a global environment
  • Willingness and ability to travel as needed, including potentially internationally
  • Fluency in the local language and English
  • Effective written and verbal communication skills
  • Strong technical aptitude and ability to learn and use multiple systems
  • High school diploma or certificate with an equivalent combination of education, training, and experience, or a Bachelor of Science, Bachelor of Arts, or equivalent qualification
  • Education in a life sciences field is preferred

Benefits

  • Fixed-term contract running through April 2027
  • The contract may be extended or converted to regular employment according to business needs, but neither outcome is guaranteed

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