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    Clinical Trial Liaison (Ctl), Hematology/Oncology (South Korea)

    Tmac
    8+ years
    Not Disclosed
    Remote, USA
    10 Oct. 3, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Territory: South Korea

    Position: Clinical Trial Liaison (CTL)

    The Clinical Trial Liaison (CTL) plays a crucial role in supporting Global Development clinical study execution as the local representative for the sponsor company in South Korea. The CTL interacts with investigator sites and various stakeholders involved in clinical trial execution.

    The CTL provides valuable regional and country-specific insights to enhance study feasibility, site identification, selection, and initiatives for patient recruitment and retention. Working collaboratively with the study team, the CTL identifies and helps resolve issues at investigator sites.

    Duties and Responsibilities:

    • Offer country/regional operational insights for site feasibility, selection, and overall patient recruitment strategies.
    • Participate in Clinical Study Team Meetings and Quality Review Meetings, providing operational input based on site visits and interactions.
    • Attend and present at investigator meetings and monitor workshops/training sessions.
    • Conduct site visits with investigator staff and/or CRO representatives, reporting back to study teams on feasibility, startup activities, enrollment, or escalated site issues.
    • Review, document, and follow up on investigator site issues, including tracking relevant metrics.
    • Provide regional operational support as the primary point of escalation for investigator sites when necessary.
    • Participate in regulatory GCP inspections and/or audits at investigator sites as the sponsor representative.
    • Complete all administrative responsibilities per SOPs and departmental guidelines, including required training, field activity documentation, expense reporting, and other assigned tasks.
    • Manage travel and local expenses in accordance with sponsor and TMAC policies.

    Qualifications and Experience:

    • Minimum Bachelor’s degree; Master’s degree or terminal degree (MD, PhD, or PharmD) preferred.
    • At least 8 years of relevant industry and/or CRO experience required.
    • Extensive experience in global clinical trial operations is essential.
    • Hematology/Oncology clinical trial experience preferred.
    • Strong medical and scientific knowledge with a solid understanding of clinical development.
    • Excellent communication skills for conveying technical and scientific information.
    • Exceptional interpersonal skills with a demonstrated ability to work collaboratively and independently.
    • Proven ability to build relationships within the external medical community.
    • Proactive and self-motivated, with the ability to align activities with clinical development plans (CDPs).
    • Strong organizational skills, with effective time management and prioritization.
    • Cross-cultural awareness and sensitivity.
    • Fluency in English and the local language of residence is required.
    • Working knowledge of ICH/GCP guidelines.
    • Proficient in computer applications, including Excel, Word, and PowerPoint.
    • Willingness to travel frequently within the assigned territory, including overnight trips.
    • Valid driver’s license is required.

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