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    Clinical Team Manager - Neuro

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

    Job Description:
    At PPD, part of Thermo Fisher Scientific, our mission is to improve health by transforming ideas into life-saving solutions. We invite you to join our dedicated and energetic teams to re-imagine health-promoting protocols.

    As a Clinical Team Manager (CTM), you will leverage your therapeutic expertise and robust tools to help clients deliver life-changing therapies to market. You will take ownership of projects, anticipate problems, and deliver results while coordinating the activities of Clinical Management members allocated to projects on a regional or country basis.

    Working closely with the Project Manager, you will ensure that vital training, tracking, and quality systems are in place for the clinical management team. You will be accountable for achieving clinical results within agreed timelines and budgets, serving as the primary contact for project sponsors regarding all clinical aspects.

    Summarized Purpose:
    You will be accountable for achieving final clinical results (usually clean data from evaluable patients as specified in the study protocol) within the specified contract period. You will interpret data on complex issues and make informed business decisions with line management support, ensuring all clinical results meet the customer's time, quality, and cost expectations.

    Essential Functions:

    • Lead all clinical operational and quality aspects of assigned studies of moderate to high complexity, ensuring compliance with ICH GCP standards. You may take on Lead CTM or Clinical Study Manager responsibilities as required.
    • Develop clinical tools (e.g., Monitoring Plans, Guidelines) alongside the Data Quality Plan. Ensure timely setup, organization, and quality of the Trial Master File sections.
    • Collaborate with project managers to prepare and present at client meetings, including bid defenses and hand-off meetings.
    • Maintain regular communication with the clinical team and other departments to ensure project timelines, resources, and quality standards are met.
    • Monitor clinical activities, prepare and track timelines, provide project status updates, and ensure contractual obligations are fulfilled.
    • Communicate with study sites regarding protocol adherence, patient participation, and case report form completion.
    • Coordinate start-up activities, ensuring that essential document quality meets regulatory compliance expectations.
    • Provide input for forecast estimates for clinical activities, manage clinical resources, and delegate responsibilities effectively.

    Education and Experience:

    • Bachelor's degree or equivalent with relevant formal academic/vocational qualifications.
    • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
    • An equivalent combination of education, training, and/or directly related experience may also be considered.

    Knowledge, Skills, and Abilities:

    • Strong leadership and mentoring skills, effective at motivating and integrating teams.
    • Excellent planning and organizational skills for effective workload prioritization.
    • Strong interpersonal and problem-solving skills for working in a multicultural matrix organization.
    • Comprehensive understanding of clinical monitoring practices, processes, and requirements.
    • Strong judgment, decision-making, and risk management skills.
    • Effective oral and written communication skills, including proficiency in English.
    • Financial competence, knowledge of budgeting, forecasting, and fiscal management.
    • Strong attention to detail and understanding of relevant regulations (e.g., ICH/GCP, FDA guidelines).
    • Proficient in standard office equipment and technology.

    Working Environment:
    At PPD, we value employee health and wellbeing and encourage a balanced work environment. You will be able to communicate effectively with diverse groups, work stationary for typical hours, and may need to travel independently up to 20%.

    Our 4i Values:
    Integrity – Innovation – Intensity – Involvement

    If our values resonate with you and you are passionate about accelerating the delivery of safe and effective therapeutics for urgent health needs, we’d love to hear from you!

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