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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. 13, 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

    Position Title: Clinical Trial Manager / Senior Clinical Trial Manager

    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 skilled Clinical Operations Professional with extensive experience in managing Phase I-III clinical trials. This role offers a unique opportunity for an individual with a solid understanding of clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements. As a Clinical Trial Manager or Senior Clinical Trial Manager, you will oversee Contract Research Organizations (CROs) and ensure the successful execution of clinical studies.

    Key Responsibilities:

    • Clinical Operations: Execute and manage clinical trials, ensuring they are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP guidelines.
    • Vendor Management: Identify, engage, and oversee CROs and other study providers (e.g., core labs, EDC providers, independent contractors) for clinical trial execution.
    • Documentation: Develop and review study-specific documentation including protocols, case report forms, study guides/manuals, informed consent forms, and clinical databases.
    • Trial Master File (TMF): Oversee the collection and management of clinical trial documentation for filing in the TMF.
    • Team Collaboration: Participate in team meetings and collaborate with other functional groups (e.g., Clinical Development, Pharmacokinetics, Regulatory, QA, Finance) to achieve study goals.
    • Issue Resolution: Follow up on team action items, and identify, escalate, and resolve issues as needed.
    • Agreement and Budget Management: Collaborate with contract specialists to review and negotiate clinical trial agreements and site-specific budgets.
    • Site Assessment: Evaluate potential clinical investigators and sites for adequacy, feasibility, and adherence to GCP.
    • Monitoring: Develop monitoring priorities and plans, conduct site visits (e.g., training, initiation, monitoring), and manage investigational product accountability.
    • Reporting: Assist in preparing safety, interim, and final clinical study reports, and resolve data discrepancies.
    • Mentorship: Provide guidance, leadership, and support to Clinical Research Associates (CRAs) assigned to clinical studies.
    • Enrollment Tracking: Prepare and track study participant enrollment projections vs. actuals, and manage study budgets.
    • Primary Contact: Serve as the main clinical operations contact for internal and external teams (clinical sites, vendors).

    Requirements and Qualifications:

    • Education: BS or MS degree in a relevant field.
    • Experience: Minimum of 5+ years of clinical operations experience in the pharmaceutical or biotech industry, with a focus on Oncology drug development.
    • Expertise: Hands-on experience with early-stage clinical trials, FDA Regulations, ICH Guidelines, and GCP.
    • Vendor Management: Proven track record in selecting and managing CROs and external resources.
    • Communication: Excellent written and verbal communication skills.
    • Teamwork: Ability to thrive in a collaborative environment, prioritize tasks, anticipate challenges, and execute goals effectively.
    • Travel: Willingness to travel (~25%).
    • Preferred: Experience in Oncology, cooperative group studies, investigator-sponsored trials, global clinical trial operations, and APAC regulations.

    Desired Skills and Experience:

    • Clinical trial management, Phase I-III, drug development, Oncology, GCP, FDA, ICH, vendor management, travel, APAC regulations.

    Application Process:

    For more information about how we handle personal data, please refer to Bayside Solutions, Inc.'s CCPA Privacy Policy.

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