Site Activation Partner – FSP, Contractor

Parexel

. Initiate and coordinate clinical trial site activation activities and essential document management .

Posted 9/29/2026full-timeSouth KoreaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial site activation, regulatory document preparation, and compliance with ICH-GCP standards. Proficient in managing essential documents and maintaining communication with study teams and investigator sites.

Highest-signal resume keywords

Clinical Trial Site ActivationRegulatory Document PreparationICH-GCP ComplianceClinical Trial Management Systems (CTMS)Investigator Initiation Packages (IIP)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesBasic Medical TerminologyAttention to DetailMultitaskingDocument Management

Soft Skills

Effective Verbal CommunicationWritten CommunicationTeam CollaborationIndependent WorkOrganizational Skills

Tools & Technologies

Microsoft SuiteElectronic Trial Master FileElectronic Investigator Site FileDocument Exchange PortalsShared Investigator Platform

Industry Keywords

Pharmaceutical IndustryCROFDA RegulationsEthics CommitteeQuality Expectations

About the role

Key responsibilities & impact

Initiate and coordinate clinical trial site activation activities and essential document management
Compile high-quality Investigator Initiation Packages leading to site initiation approval
Resolve and escalate site issues and coordinate supporting roles to ensure timely site activation
Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
Support central and local ethics committee packages, submissions, communications, and approvals
Prepare, handle, and distribute clinical documentation and reports according to scope and SOPs
Support Shared Investigator Platform activities aligned with Pfizer strategy
Manage essential documents and updates throughout the study lifecycle, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
Maintain IRB/Ethics Committee activities and file documents to the Trial Master File
Conduct periodic quality reviews of study files for accuracy and completeness
Maintain clinical trial systems tracking site compliance and performance
Support investigator sites and study teams with site audits and responses
Maintain communication with study teams and investigator sites and provide country- and site-level updates
Establish tools and disseminate ethics and site approval updates to stakeholders
Conduct awareness sessions on client requirements and ongoing documentation compliance
Identify and resolve investigator site issues and align on corrective and preventative actions
Act as a Site Activation Partner point of contact or subject matter expert on systems, processes, projects, and global initiatives
Support mentoring of new hires
Complete required training, timesheets, expense reports, and CV updates
Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

Requirements

What you’ll need

Minimum 2 years' relevant experience in clinical site management
Experience working in the pharmaceutical industry or CRO in study site activation preferred
Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations
Knowledge of clinical research and development processes and key operational elements of a clinical trial
Understanding of quality expectations and emphasis on right first time
Compliance with applicable company, regulatory, and country requirements
Attention to detail and disciplined approach
Ability to work independently and as a team member
Ability to organize tasks, time, and priorities and multitask
Basic medical terminology and GCP requirements
Proficiency in computer operations and ability to use and learn multiple systems independently
Proficiency with Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File, Electronic Investigator Site File (e.g. Florence), document exchange portals, Shared Investigator Platform, and ethics/national networks/governing bodies portals and platforms as needed
Flexibility to work off-hours in a global environment when applicable
Ability to travel as needed, including possible international travel
Must be fluent in the local language and English
Effective verbal and written communication skills
Good technical skills and ability to learn and use multiple systems
School diploma or certificate with equivalent combination of education, training, and experience, or Bachelor of Science/Bachelor of Arts or equivalent
Education in a life sciences discipline preferred

Benefits

Comp & perks

Fixed-term contract until April 2027
Contract may be extended or converted to regular employment based on business needs, but not guaranteed