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    Clinical Monitoring Oversight Manager - Raleigh, United States - Merz North America

    Merz North America
    Merz North America Raleigh, United States

    1 week ago

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    Description
    Sponsor oversight of monitoring activities to ensure the effective and efficient delivery of the operational aspects in accordance with applicable regulations, requirements, and procedures

    Essential Duties andResponsibilitiesClinical Projects Oversight:
    Oversee site and monitoring activities across clinical studies to maintain quality standardsBuild and maintain site relationships across clinical studiesOversee external CRA training to ensure compliance is maintainedReview percentage of trip reports, metrics, protocol deviations and follow-up items, to evaluate compliance and ensure corrective and preventative actions are implementedIdentify monitoring trends across clinical studies and communicate them within trial team and Clinical Operations TeamInteract with Trial Team members and CRO/vendor personnel, as needed

    Clinical Project Quality Management:
    Oversee site inspection readiness, including health of Trial Master File (TMF)

    Support site and Sponsor audits and inspectionsParticipate in investigator meetings and trainings to ensure qualityPerform co-visits with external CRAs for site initiation visits and selected monitoring visitsConduct additional checks as outcome of internal medical monitoring/clinical checks, as neededVendor Qualification and Oversight:
    Participate in KPI determination for CROs and vendorsAttend governance meetings with vendors, when applicableEnsure quality of vendor's monitoring systems, tools and templates including vendor selection processesOversee monitoring visit scheduling and monitoring performance metrics via spot checksLiaise with CPMs to ensure that vendor proposals for monitoring tasks are adequate

    Process Development:
    Develop and maintain monitoring SOPs, templates, and tools, including risk-based and centralized monitoringSet-up and maintain a QTL database inclusive trackingReporting:Regular reporting to senior management of the Clinical Projects Groupas necessary

    Change Management:

    Support the implementation of new processes across R&D and engage in internal team trainings as neededOther duties as assigned:Travel up to 50% RequiredJob Related Qualifications / SkillsProfessional ExperienceRequired:6+ years' Experience in different medical indications, study designs and phases of clinical development of medicinal products or medical devices5+ years' experience as a clinical research associate2+ years experience as a Lead CRA, Clinical Trial Lead or equivalentExperience in clinical study processesPrevious experiences in the leadership of interdisciplinary and international teamsKnowledge, Skills, and AbilitiesRequired:Basic statistical understandingFluent business EnglishExperience with CTMS, IVRS and EDC systemExcellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reports, and presentations EducationRequired:Bachelor's degree in life sciences or medical health or other professional qualifications equivalent to university degreeEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

    However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

    41 CFR c)
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