Job Overview:

The TMF Manager will work with cross-functional teams for TMF management and provide support and subject matter expertise to key stakeholders. Responsible for the TMF Quality review and availability of TMF documents for assigned trials according to established timelines.

Responsibilities

Accountable for the ‘health of the Trial Mater File (TMF); the CTT will be responsible for the content of the TMFWork with the Clinical Trial Team (CTT) and CRO to populate the TMF Management Plan; continuously review and ensure the plan is current and up to dateEnsure successfully delivery of TMF Management Plan and document any deviationsMonitor the CTT/CRO compliance with TMF process within a trial in a timely mannerEnsure appropriate KPIs and metrics are defined for the studyEnsure the health of the TMF by monitoring and reviewing KPIs and metricsDefine the overall Quality Review Strategy for the study; make adjustments to the plan based on review of KPIs and metricsManage the TMF close out activitiesPoint of contact for TMF related questionsAccountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutionsDetermines the number of TMF Analysts required to support Quality Review ActivitiesOversee and coordinate the TMF Quality Review activities performed by TMF AnalystsProvide training/mentoring to TMF Analysts 

Qualifications

Bachelor’s Degree (or equivalent) in a directly related health science disciplineMinimum 5 years pharmaceutical / biotechnology industry experienceMinimum 3 years records management experience in a GCP-regulated environment and with Essential TMF Documents.Strong TMF Reference Model and eTMF system (Veeva Vault eTMF preferred) experienceExtensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelinesKnowledgeable in domestic and global regulatory requirements and guidanceWorking knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferredAttention to detailGood written and verbal communication skillsExcellent interpersonal and organizational skillsAbility to work independently, self-supportedAbility to manage multiple projects and to effectively prioritize tasksAbility to manage external vendorsStrong interpersonal skills and ability to manage all levels within a cross-functional organization through inspiration and influenceContinuous improvement mindset and ability to function independently with a proactive, self-starter attitude.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com