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    Sr. Clinical Trial Coordinator (Etmf) - Fsp

    Thermo Fisher Scientific
    4-5 years
    Not Disclosed
    Remote
    10 Aug. 6, 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, 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

    Position: Project Coordinator

    Work Schedule: Standard (Mon-Fri)

    Environmental Conditions: Office

    Job Description:

    Summary:

    The Project Coordinator provides essential administrative and technical support to the Project Team, facilitating project activities and acting as a cross-functional liaison. This role includes onboarding new staff, providing training as needed, and supporting departmental and cross-functional initiatives aimed at process improvements and enhancements.

    Key Responsibilities:

    • Project Coordination: Manage and complete functions related to assigned trial activities, as detailed in the task matrix. Coordinate, oversee, and ensure timely, budget-compliant, and high-quality completion of tasks.
    • Documentation and Systems Management: Maintain and manage study-specific documentation, including global support for systems, tools, and trackers such as study team lists, project-specific training requirements, system access, and project activity plans. Ensure the (e)TMF is up-to-date by following review schedules and documenting findings.
    • Administrative Support: Process and manage documents for Client (e)TMF, conduct (e)TMF reviews, perform mass mailings, provide reports and documents to internal team members, and support the scheduling and organization of client/internal meetings, including taking meeting minutes.
    • Regulatory and Site Support: Review and track local regulatory documents, transmit documents to clients and centralized IRB/IEC, analyze and reconcile study metrics, and assist with site documentation clarification and resolution. Maintain vendor trackers and assist with the distribution of Investigator Site File (ISF) and Pharmacy binder materials.
    • Additional Tasks: Support RBM activities, handle study-specific translation materials and translation QC, and attend and take notes at kickoff meetings when required.

    Education and Experience:

    • Bachelor’s degree preferred.
    • 4-6 years of relevant experience in clinical trials, eTMF (preferably Veeva, but other experiences considered), CTMS, Essential Documents, and ICH GCP Guidelines.

    Knowledge, Skills, and Abilities:

    • Strong knowledge of Clinical Trials and experience with eTMF, CTMS, Essential Documents, and ICH GCP Guidelines.
    • Excellent business communication skills, both written and verbal.
    • Ability to work effectively both independently and as part of a team.
    • Strong organizational skills with attention to detail and the ability to handle multiple tasks efficiently.
    • Proven ability to analyze project-specific data/systems for accuracy and efficiency.
    • Strong customer focus with flexibility and adaptability to changing project timelines.
    • Ability to maintain knowledge of applicable country regulations, ICH GCP, and organization/Client SOPs for all project aspects.
    • Proficiency in English and local language skills as needed. Good presentation skills.
    • Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint), and the ability to master clinical trial database systems.
    • Self-motivated with a positive attitude and strong interpersonal skills.

    Training:

    • Must successfully complete the PPD clinical training program.

    Why Join Us?

    • Professional Growth: We are committed to creating successful careers with significant professional development opportunities.
    • Collaborative Environment: Be part of a team that values talent, experience, and integrity to drive clinical development forward.
    • Competitive Benefits: Enjoy a comprehensive benefits package, work-life balance, and a supportive work environment.

    Cytel Inc. is an Equal Employment / Affirmative Action Employer. We consider all applicants without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other protected characteristic.

    Agency Notice:

    Cytel does not accept referrals from employment businesses or agencies without prior written authorization from our human resources department. Unauthorized referrals will not incur any liability or fees for Cytel.

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