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    Clinical Trial Manager / Senior Clinical Trial Manager

    Bayside Solutions
    5+ years
    $156,000 - $187,200 per year
    Santa Clara
    10 Aug. 6, 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

    Clinical Trial Manager / Senior Clinical Trial Manager

    Position Type: W2 Contract-to-Hire
    Salary Range: $156,000 - $187,200 per year
    Location: Redwood City, CA - Hybrid or Remote (PST)

    Job Summary:

    We are seeking a seasoned Clinical Operations Professional for a unique opportunity to manage Phase I-III clinical trials. The ideal candidate will possess technical expertise in clinical operations, Good Clinical Practice (GCP), and US Food and Drug Administration (FDA) regulatory requirements. As a Clinical Program Manager, you will oversee Contract Research Organizations (CROs) and ensure the successful execution of clinical studies.

    Key Responsibilities:

    • Clinical Operations: Execute and manage assigned clinical trials according to department and corporate objectives.
    • Vendor Management: Oversee CROs and other clinical study providers to ensure timely, budget-compliant, and regulatory-compliant study execution.
    • Documentation: Review and contribute to the development of study-specific documentation, including protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases.
    • Study Oversight: Monitor and manage clinical trial documentation, including Trial Master File (TMF) and study monitoring reports.
    • Team Collaboration: Participate in team meetings and collaborate with various functional groups (Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study objectives.
    • Contract Negotiation: Collaborate with contract specialists to review and negotiate clinical trial agreements and site-specific budgets.
    • Site Management: Assess and manage clinical investigators and sites, ensuring adherence to GCP and evaluating facilities and personnel.
    • Monitoring: Develop monitoring priorities and plans in collaboration with CROs; conduct site visits (training, initiation, monitoring).
    • Product Accountability: Manage investigational product accountability and reconciliation processes.
    • Reporting: Assist with preparing safety, interim, and final clinical study reports, and resolve data discrepancies.
    • Leadership: Provide guidance and support to Clinical Research Associates (CRAs) and track study participant enrollment and budgets.
    • Primary Contact: Serve as the main contact for internal and external teams related to assigned studies.

    Requirements:

    • Education: BS or MS degree in a relevant field.
    • Experience: Minimum of 5+ years in clinical operations within the pharmaceutical or biotech industry, with substantial experience in Oncology drug development.
    • Skills: Hands-on experience with early-stage clinical trials, strong knowledge of FDA regulations, ICH guidelines, and GCPs.
    • Vendor Management: Proven track record in selecting and managing CROs and external resources.
    • Communication: Excellent written and verbal communication skills; ability to manage multiple tasks and anticipate challenges.
    • Travel: Willingness to travel approximately 25%.
    • Preferred: Experience with cooperative group studies, investigator-sponsored trials, global clinical trial operations, and knowledge of APAC regulations.

    Desired Skills:

    • Clinical trial management (Phase I-III)
    • Drug development and Oncology expertise
    • Vendor management and global clinical trial operations
    • Knowledge of APAC regulations

    About Bayside Solutions, Inc.:

    Bayside Solutions, Inc. may collect personal information during the application process. For more information, please refer to Bayside Solutions, Inc.'s CCPA Privacy Policy.

    If you are a dynamic professional looking to impact the future of clinical trials and drug development, apply today!

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