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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 TMF
• Work 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 date
• Ensure successfully delivery of TMF Management Plan and document any deviations
• Monitor the CTT/CRO compliance with TMF process within a trial in a timely manner
• Ensure appropriate KPIs and metrics are defined for the study
• Ensure the health of the TMF by monitoring and reviewing KPIs and metrics
• Define the overall Quality Review Strategy for the study; make adjustments to the plan based on review of KPIs and metrics
• Manage the TMF close out activities
• Point of contact for TMF related questions
• Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions
• Determines the number of TMF Analysts required to support Quality Review Activities
• Oversee and coordinate the TMF Quality Review activities performed by TMF Analysts
• Provide training/mentoring to TMF Analysts 
  

Qualifications

• Bachelor’s Degree (or equivalent) in a directly related health science discipline
• Minimum 5 years pharmaceutical / biotechnology industry experience
• Minimum 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) experience
• Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
• Knowledgeable in domestic and global regulatory requirements and guidance
• Working knowledge of Regulatory Agency Audits and NDA/MAA Submission triggered Inspections preferred
• Attention to detail
• Good written and verbal communication skills
• Excellent interpersonal and organizational skills
• Ability to work independently, self-supported
• Ability to manage multiple projects and to effectively prioritize tasks
• Ability to manage external vendors
• Strong interpersonal skills and ability to manage all levels within a cross-functional organization through inspiration and influence
• Continuous 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