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    Ctm

    Thermo Fisher Scientific
    1-3 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

    Job Description

    At Thermo Fisher Scientific, you’ll find meaningful work that impacts the world on a global scale. Join our team in bringing our mission to life—enabling our customers to make the world healthier, cleaner, and safer. We provide the resources to support your career growth while advancing science through the development and delivery of life-changing therapies. With clinical trials conducted in over 100 countries and innovative frameworks for clinical research, our work spans laboratories, digital platforms, and decentralized clinical trial services. Your commitment to delivering quality and accuracy will improve health outcomes for people and communities—today and in the future.

    Summarized Purpose: As a Clinical Trial Manager (CTM), you will be responsible for achieving clinical deliverables, such as clean data from patients, within the specified timeframes in customer contracts. You will interpret project issues, make informed business decisions with support from expert team members or line managers, and ensure all clinical deliverables meet time, quality, and cost expectations. You will also ensure clinical activities are conducted within the scope of the contract and maintain project profitability by efficiently managing the clinical team. This role typically involves working on low-to-moderate complexity projects within a team of Clinical Trial Managers (CTMs).

    Key Responsibilities:

    • Manage all clinical operational and quality aspects of assigned studies, ensuring compliance with ICH GCP standards.
    • Develop clinical tools such as Supervising Plans and Monitoring Guidelines, and contribute to the development of the Master Action Plan (MAP) for clinical documents.
    • Ensure timely organization and quality control of the Trial Master File (TMF).
    • Collaborate with project managers and clinical teams to prepare and present at client meetings, including bid defense and hand-off meetings.
    • Communicate with the team regularly to maintain timelines, resource allocation, and quality standards.
    • Ensure clinical monitoring processes are implemented and aligned with corporate policies, and manage the archiving of study documents.
    • Provide clinical activity status updates, manage timelines, and implement recovery actions as needed to ensure projects are on track.
    • May interact with study sites to address issues related to protocols, patient participation, and documentation.
    • Oversee ethics committee and regulatory submissions, ensuring that documents meet regulatory requirements.
    • Manage clinical resources, assign responsibilities, and identify additional resource needs for projects.

    Education and Experience:

    • Bachelor’s degree or equivalent and relevant formal academic or vocational qualifications.
    • A minimum of 5+ years of experience in clinical trial management or a related field.

    Knowledge, Skills, and Abilities:

    • Strong leadership skills, with the ability to mentor and motivate teams.
    • Excellent planning and organizational skills to prioritize workloads effectively.
    • Strong interpersonal and problem-solving skills, especially in multicultural and matrix environments.
    • Familiarity with clinical monitoring practices and global regulations (e.g., ICH GCP, FDA guidelines).
    • Solid judgment and decision-making abilities.
    • Proficiency in English and strong communication skills.
    • Financial acumen, with experience in budgeting, forecasting, and fiscal management.
    • Attention to detail and strong digital literacy, including proficiency with systems such as Outlook, Excel, and Word.

    Benefits: We offer a competitive salary, an annual incentive plan bonus, healthcare coverage, and a comprehensive benefits package. Thermo Fisher Scientific provides a dynamic work environment with excellent career development opportunities, fostering a culture built on integrity, intensity, involvement, and innovation.

    Join a global team of over 100,000 colleagues working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diversity in experiences, backgrounds, and perspectives is celebrated.

    Apply today at Thermo Fisher Careers.

    Accessibility/Disability Access: Thermo Fisher Scientific is committed to providing accessibility accommodations for job seekers with disabilities during the application process. If you require assistance, please contact us at 1-855-471-2255. This number is reserved for disability-related requests only.

    Thermo Fisher Scientific is an equal opportunity employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.

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