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    Sr. Clinical Trial Coordinator (Etmf) - Fsp

    Thermo Fisher Scientific
    4-6 years
    Not Disclosed
    Remote, USA
    10 July 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Job Description

    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    Summarized Purpose:
    We are looking for an organized and technically skilled individual to provide administrative and technical support to our Project Team. The role involves coordinating and facilitating project activities, potentially serving as a study lead and acting as a cross-functional liaison. The successful candidate will also provide training to new staff during the onboarding phase and support departmental and cross-functional initiatives aimed at process improvements and enhancements.

    Essential Functions and Responsibilities:

    • Coordinate, oversee, and complete functions on assigned trial activities as detailed in the task matrix.
    • Perform department, internal, country, and investigator file reviews, documenting findings in the appropriate system.
    • Ensure allocated tasks are completed on time, within budget, and to a high-quality standard, proactively communicating any risks to project leads and line managers as appropriate.
    • Support the maintenance of study-specific documentation and global systems, tools, and trackers, including study team lists, tracking project-specific training requirements, and system access management.
    • Ensure the electronic Trial Master File (eTMF) is up to date by following file review schedules and documenting findings in the appropriate system.
    • Provide system support for GoBalto and eTMF.
    • Support Risk-Based Monitoring (RBM) activities.
    • Perform administrative tasks on assigned trials, including processing documents sent to the Client (eTMF), performing eTMF reviews, managing mass mailings and communications, and providing documents and reports to internal team members.
    • Support the scheduling and organization of client and internal meetings, including the completion of related meeting minutes.
    • Review and track local regulatory documents and transmit them to clients and centralized IRB/IEC.
    • Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution of findings related to site documentation.
    • Maintain vendor trackers and assist with the coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials, as well as non-clinical study supplies to sites.
    • Assist with study-specific translation materials and translation quality control upon request.
    • May attend Kick-off meetings and take notes when required.

    Education and Experience:

    • Bachelor's degree preferred.
    • 4-6 years of previous experience in a relevant role, providing the knowledge, skills, and abilities required for this job.

    Knowledge, Skills, and Abilities:

    • 4-5 years of experience and strong knowledge of clinical trials, including experience with electronic Trial Master File (eTMF) systems (preferably Veeva, but other experiences are considered), Clinical Trial Management Systems (CTMS), essential documents, and ICH GCP guidelines.
    • Excellent business communication skills.
    • Ability to work both independently and as part of a team.
    • Strong organizational skills and attention to detail, with a proven ability to handle multiple tasks efficiently and effectively.
    • Proven ability to analyze project-specific data/systems to ensure accuracy and efficiency.
    • Strong customer focus and excellent interpersonal skills.
    • Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines.
    • Good working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution, and closeout.
    • Excellent English language and grammar skills, with proficiency in local languages as needed.
    • Good presentation skills.
    • Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint), with the ability to master all clinical trial database systems.
    • Ability to successfully complete PPD clinical training program.
    • Self-motivated with a positive attitude and strong interpersonal skills.

    About the Company:
    IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to pushing the boundaries of human and data science to make the biggest impact possible and help our customers create a healthier world. Learn more at IQVIA Careers.

    Location: Kochi, India

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