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    Amendment Implementation Specialist

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Remote
    10 Oct. 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, 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: Amendment Implementation Specialist
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    Job Description:

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life—enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while advancing science through the research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing development of innovative frameworks for clinical research, your dedication to quality and accuracy will improve health outcomes for communities worldwide.

    Discover Impactful Work:
    The Amendment Implementation Specialist is responsible for executing amendment activities within assigned projects, ensuring that deliverables meet customer expectations and contractual milestones through accurate projections, report updates, and ongoing risk assessments.

    A Day in the Life:

    • Support the amendment implementation strategy at country and site levels, either regionally or globally.
    • Clarify amendment scope, classification, and timelines.
    • Manage requests for country resources in Clarity.
    • Collaborate with the project team on amendment planning.
    • Discuss financial coverage for amendments with the Project Lead.
    • Track amendment-related actions and facilitate updates within relevant systems.
    • Schedule and conduct progress check calls with local teams.
    • Update Principal Investigator Amendment Notifications and Amendment Implementation Letters.
    • Liaise with the Regulatory Affairs Lead and project team to assess submission requirements and timelines.
    • Update forecasting and actuals for amendment-related units per Clarity monthly deadlines.
    • Inform project team members upon completion of amendment activities.
    • Assist in risk identification and contingency planning for amendments.
    • Introduce roles and responsibilities to local teams.
    • Request access to study-related systems.

    Keys to Success:

    • Education:
      Bachelor’s degree or equivalent formal academic/vocational qualification.

    • Experience:
      Minimum of 2 years of relevant experience.

    • Knowledge, Skills, and Abilities:

      • Strong understanding of PSC tasks, eTMF, File Review processes, and client-specific manuals.
      • Awareness of audit/inspection processes and relevant rules.
      • Proficiency in applications like Excel; ability to analyze project-specific data for accuracy.
      • Excellent organizational skills and attention to detail, with the capacity to manage multiple tasks efficiently.
      • Strong customer focus and flexibility to adapt to changing timelines.
      • Knowledge of ICH GCP and the clinical trial life cycle.
      • Advanced English proficiency (verbal and written).
      • Good computer skills, including proficiency in MS Office (Word, Excel, PowerPoint).
      • Strong collaboration and communication skills; ability to shift priorities as needed.
      • Effective negotiation skills and the ability to multitask.
      • Capacity to work under pressure and maintain attention to detail.

    Physical Requirements / Work Environment:

    • Office environment with exposure to electrical equipment.
    • May require different shifts and long, varied hours on occasion.
    • Occasional travel may be necessary.
    • Frequently stationary for 6-8 hours per day with repetitive hand movements.
    • Light to moderate lifting (15-20 lbs) may be required.
    • Ability to communicate information effectively and understand spoken words.
    • Works independently with minimal guidance, requiring periods of intense concentration.
    • Performs a wide range of tasks based on variable demands and conditions.

    Benefits:
    We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific fosters an innovative, forward-thinking organization with outstanding career development prospects. Our exciting company culture is built on integrity, intensity, involvement, and innovation.

    Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Join over 100,000 colleagues who share our values—Integrity, Intensity, Innovation, and Involvement—working together to solve complex scientific challenges and support patients in need.

    #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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