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Clinical Operations Manager

San Diego Metro Area, California

Post Date: 05/26/2017 Job ID: JN -052017-19150
  • Clinical Trial Manager, Clinical Operations
  • The Clinical Trial Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, regulations/guidelines, and applicable SOPs/WPs. They are the primary operational contact for the study and lead the cross-functional global team for execution of the study. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. They should have the command of projects
  • Major Responsibilities:
    Financial Planning and Management
    Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget,
    Takes ownership and accountability for the development/management/reconciliation of overall study budget(s),
    Development/management of vendor scope of work (SOW) per contract, quality, and budget,
    Review/approval of vendor invoices and management of accruals and SOW changes,

    Project Management
    Drive study execution utilizing available performance metrics and quality indicators,
    Oversight of clinical monitoring quality and adherence to established processes and plans,
    Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make the appropriate trade-offs of balancing risks with study deliverables and costs,
    Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs,
    Maintenance/updating of data as appropriate in project management tools including CTMS and MS Project
    Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation,

    Study Planning and Conduct
    Facilitation of country and site feasibility/selection processes with use of robust data,
    Operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.,
    Oversight of investigational product [IP] supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC] and recommend appropriate trade-off to balance risks and study execution deliverables,
    Development of the subject recruitment/retention strategy and related initiatives,
    Participation in clinical service provider (vendor) selection, specification development, and management/oversight,
    Oversight of TMF set-up, ongoing quality review and oversight of cross functional QC of TMF, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance,
    Development/coordination of study training for study team, investigational sites, and vendors,
    Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications,
    Participation in Serious Adverse Event (SAE) reconciliation process, and
    Proactive management of issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.

  • BA / BS Degree in relevant discipline
    Minimum 4 years clinical study management experience including serving as study lead and multinational experience
    Experience in oversight of CRO study execution preferred
    Clinical trial project management skills,
    Financial budgeting and forecasting skills,
    Leadership / influence management skills,
    In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes,
    Ability to effectively lead a cross-functional team in a matrix environment,

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