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    Study Start-Up Country Specialist Ii (Row)

    Caidya
    2+ years
    Not Disclosed
    Remote
    10 Nov. 4, 2024
    Job Description
    Job Type: Full Time 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

    Job Title: Study Start-Up Country Specialist II (ROW)
    Job Location: Australia, Homebased

    Job Overview:
    The Study Start-Up Country Specialist II (SSUCS II) collaborates with project teams and the Study Start-Up (SSU) Manager to perform essential study start-up tasks within their country or countries of expertise. Responsibilities include study feasibility assessments, facilitating site contracts and budget negotiations, reviewing document translations, and submitting to regulatory bodies (Competent Authority and Ethics Committee - IRB/IEC), among other start-up activities as assigned. The SSUCS II ensures the collection of essential regulatory documents from sites and prepares, completes, and reviews country-related submission packages in compliance with ICH-GCP and applicable regulations, laws, and ethical standards within established timelines and quality standards. This role may also involve coaching and mentoring junior specialists.

    Job Duties and Responsibilities:

    • Provide country-level expertise and support to the SSU team and project team.
    • Assist the Legal team with completing and distributing Confidential Disclosure Agreements (CDAs), providing necessary support for execution with sites.
    • Build and maintain relationships with sites and investigators within the country of expertise.
    • Participate in site and investigator identification and selection, including national lead investigators, providing submission strategies based on practical experience.
    • Facilitate the distribution and collection of Feasibility Questionnaires (FQs) to sites in assigned countries, following up to ensure interest and adherence to study timelines.
    • Oversee the distribution, collection, and review of site essential documents, coordinating with assigned CRAs for submission and essential document release.
    • Create, translate, and review regulatory documents tailored to the submission requirements of applicable Regulatory Bodies.
    • Draft and review local language documents to facilitate interaction with local Regulatory Bodies.
    • Assist with the creation, translation, and review of regulatory documents for Clinical Trial Applications (CTA) and submissions to Regulatory Bodies.
    • Maintain submission information for applicable Regulatory Bodies and similar data for assigned countries.
    • Under supervision, perform quality checks (QC) on submission dossiers for Regulatory Bodies.
    • Provide submission strategies based on practical experience.
    • Execute submissions or notifications to applicable Regulatory Bodies.
    • Draft cover letters, review translations, and communicate with Regulatory Bodies regarding Grounds for Non-Acceptance (GNA) or deficiencies as needed.
    • Adapt Country and/or Site Informed Consent Forms (ICF).
    • Review and negotiate site study budgets, acting as a liaison between the Legal department and sites.
    • Accurately enter SSU status and regulatory document data into applicable tracking systems and the Trial Master File (TMF).
    • May coach, mentor, or onboard new hires or junior specialists.
    • Contribute to functional improvement initiatives.
    • Perform other duties as assigned by the SSU Manager, SSU & Regulatory Lead, Country Manager, Director of SSU, or designee based on project-specific needs.

    Supervisory Responsibilities: None

    Job Requirements:

    Education

    • Bachelor’s degree in a healthcare or life science field or equivalent experience.

    Experience

    • Minimum of 3 years of experience as an SSU Specialist or in a regulatory specialist position, preferably in the CRO or pharmaceutical industry.

    Skills/Competencies

    • Strong written and verbal communication skills.
    • Native-level or equivalent fluency in the local language to translate/review/draft local language documents, if applicable.
    • Strong interpersonal skills.
    • Comprehensive knowledge of ICH-GCP guidelines.
    • Proficiency in medical terminology.
    • Ability to exercise judgment within defined procedures and practices to determine appropriate actions independently.
    • Attention to detail and strong problem-solving skills.
    • Ability to work in a matrix environment.
    • Strong time management and organizational skills.
    • Fluent in English and the local country language.

    Capabilities

    • Demonstrated experience in SSU activities and in preparing regulatory submission packages according to ICH-GCP guidelines and country-specific standards.
    • Adhere to study timelines, document challenges, collect necessary documents, and communicate updates to the SSU Manager and/or Project Manager (PM).
    • Proficient computer skills, including Microsoft Office.

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