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    Sr. Project Support Coordinator

    Thermo Fisher Scientific
    4+ years
    Not Disclosed
    Remote
    10 Sept. 11, 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, 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:
    Flexible/Other

    Environmental Conditions:
    Office-based

    Job Description:

    • Coordinates, oversees, and completes assigned trial activities as outlined in the task matrix.
    • Conducts department, internal, country, and investigator file reviews as assigned, documenting findings, following up for resolution, and escalating issues when necessary.
    • Ensures tasks are completed on time, within budget, and at a high-quality standard. Identifies variances (overburn/underburn) and adjusts task distribution for self and junior PSCs based on workload.
    • Supports the maintenance and oversight of study-specific documentation, including global support with systems, tools, and trackers. This includes managing study team lists, tracking project-specific training requirements, system access for organizations/vendors/clients, and monitoring project-level activity plans.
    • Provides system support (CTMS, Oracle Activate & eTMF), managing access requests, monitoring study-level documents, ensuring audit readiness, addressing non-compliance, and proposing resolutions to the study team.
    • Performs administrative tasks such as processing documents, conducting eTMF reviews, coordinating issue resolution, managing mass communications, and providing reports to internal team members.
    • Schedules and organizes client and internal meetings, including preparation and distribution of meeting minutes and follow-up on action items.
    • Exports, reconciles, and analyzes study metrics reports, identifying potential issues, particularly when involved in a Lead role.
    • Maintains vendor trackers and ensures accuracy.
    • Coordinates and compiles Investigator Site Files (ISF) templates and pharmacy binders under the guidance of the Clinical Team Manager.
    • Attends Kick-off and Project Launch meetings, taking notes and supporting study setup when required.

    Education and Experience:

    • High school/secondary school diploma or equivalent, with relevant formal academic or vocational qualifications.
    • Technical positions may require certification.
    • A minimum of 4 years of experience in a similar role.

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