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    Sr. Clinical Trial Coordinator - Etmf

    Thermo Fisher Scientific
    4-6 years
    Not Disclosed
    Remote
    10 Sept. 27, 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

    Work Schedule

    Standard: Monday to Friday
    Environmental Conditions: Office

    Job Description

    Summarized Purpose:

    This role provides essential administrative and technical support to the Project Team. You will coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. Additionally, you will support onboarding by acting as a buddy and providing training to new staff as needed. You will also engage in departmental and cross-functional initiatives aimed at process improvements and enhancements.

    Essential Functions and Other Job Information:

    • Depending on the specific role (Central or Local), coordinate, oversee, and complete functions for assigned trial activities as outlined in the task matrix.
    • Conduct department, internal, country, and investigator file reviews as assigned, documenting findings in the appropriate systems.
    • Ensure that allocated tasks are completed on time, within budget, and to high-quality standards. Proactively communicate any risks to project leads and the line manager.
    • Maintain study-specific documentation and provide global support with various systems, tools, and trackers, including study team lists, project-specific training requirements, and system access management for organization/vendor/client.
    • Keep the electronic Trial Master File (eTMF) up to date by following file review schedules and documenting findings.
    • Provide system support (e.g., GoBalto & eTMF) and assist with Risk-Based Monitoring (RBM) activities.
    • Perform administrative tasks for assigned trials, including timely processing of documents sent to Client eTMF, conducting eTMF reviews, and managing mass mailings and communications as needed.
    • Support the scheduling and organization of client and internal meetings, including taking meeting minutes.
    • Review and track local regulatory documents and transmit documents to clients and centralized IRB/IEC.
    • Analyze and reconcile study metrics and findings reports, assisting in the clarification and resolution of findings related to site documentation.
    • Maintain vendor trackers and assist in coordinating, compiling, and distributing Investigator Site File (ISF) and Pharmacy binder materials, as well as non-clinical study supplies to sites.
    • Assist with study-specific translation materials and quality control for translations upon request.
    • Attend kickoff meetings and take notes as required.

    Education and Experience:

    • Bachelor’s degree preferred.
    • 4-6 years of relevant experience that provides the knowledge, skills, and abilities necessary for this role.

    Knowledge, Skills, and Abilities:

    • 4-5 years of experience with a strong understanding of clinical trials, eTMF (preferably Veeva), Clinical Trial Management Systems (CTMS), essential documents, and ICH GCP guidelines.
    • Excellent business communication skills.
    • Ability to work effectively in a team or independently as required.
    • Strong organizational skills and attention to detail, with a proven ability to manage multiple tasks efficiently.
    • Ability to analyze project-specific data and systems to ensure accuracy and efficiency.
    • Strong customer focus and adaptability to reprioritize workload to meet changing project timelines.
    • Solid understanding of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs for all aspects of project implementation, execution, and closeout.
    • Excellent English language and grammar skills, with proficiency in local languages as needed.
    • Good presentation skills and proficiency in MS Office (Word, Excel, PowerPoint), with the ability to master clinical trial database systems.
    • Ability to successfully complete the PPD clinical training program.
    • Self-motivated with a positive attitude and strong interpersonal skills.

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