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    Clinical Operations Associate

    Daiichi-Sankyo
    1+ years
    Not Disclosed
    Basking Ridge
    10 July 3, 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, 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: Clinical Operations Associate

    Company Overview: Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is committed to advancing pharmaceutical therapies through innovation to meet global medical needs. With a presence in over 20 countries and a workforce of 16,000, Daiichi Sankyo leverages its scientific expertise and robust pipeline to focus primarily on oncology, rare diseases, and immune disorders under its 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology."

    Responsibilities:

    • Reconcile TMF document trackers from the DS TMF team and/or CRO with the document archive, escalating any discrepancies to supervisors.
    • Distribute essential study documents to CROs and vendors as needed.
    • Upload country and study level documents to the Trial Master File (TMF) system.
    • Ensure accuracy of Essential Document Listings throughout the trial duration.
    • Provide administrative support to study teams, including preparing meeting logistics, distributing agendas, and documenting meeting minutes for various stakeholders.
    • Coordinate with DS Regulatory Operations to publish trial information on public forums like clinicaltrials.gov.
    • Manage access to study systems for internal DS team members and CRO personnel.
    • Collaborate with Insurance Brokers to secure study site insurance coverage.
    • Oversee vendor activities related to lab logistics and other assigned tasks.
    • Track study metrics such as site start-up, investigator/site performance, recruitment progress, regulatory document submission, TMF filing, and quality control activities.
    • Maintain spreadsheets to track items like vendor invoices as required.
    • Participate in training sessions and contribute to departmental objectives.
    • Assist in planning and executing clinical studies under the guidance of a Clinical Operations Manager or above, ensuring compliance with protocols, GCPs, SOPs, FDA/EU regulations, and ICH guidelines.
    • Focus on providing clinical administrative support and monitoring CRO and vendor performance against project milestones as per Daiichi Sankyo Clinical Oversight Plan (CSOP).

    Qualifications:

    • Education: Bachelor's Degree (preferably in Life Sciences) from an accredited college or university.
    • Experience: At least 1 year of relevant experience in clinical development, including pharmaceuticals, medical devices/diagnostics, Academic Research Organizations (AROs), or Contract Research Organizations (CROs). CRA experience is preferred. Experience in a medical environment (e.g., Study Site Coordinator) is also advantageous.
    • Skills: Strong organizational skills with the ability to manage multiple tasks effectively. Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Outlook). Excellent verbal and written communication skills in English.
    • Travel: Ability to travel occasionally, up to 5%.

    Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer that values individual contributions and fosters a collaborative working environment. We provide comprehensive training, tools, and support to empower our employees to achieve success and contribute to our mission. Join us at Daiichi Sankyo, Inc. and be part of our commitment to innovation in pharmaceuticals.

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