QC Manager

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

QC Manager- Novartis

Job Purpose

Responsible for the Quality Control of content and availability of essential TMF documents for assigned trials according to established timelines.

Main Duties

• Single Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team for TMF related questions and serves as Subject Matter Expert on TMF Quality Control
• Maintain documentation of appropriate oversight of all external partner’s work specific to document management within the TMF
• Responsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanisms
• Translate trial information, processes and regulations into TMF documentation
• Responsible for conducting specified quality controls on some essential clinical documents according to established processes
• Track progress to key quality indicators (KQIs), and overall compliance to TMF processes and regulations
• Oversight of TMF QC Specialists and monitor QC performed by the TMF QC specialists on assigned trials
• Provide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/QC
• Maintain documentation of appropriate oversight Of Vendor TMF Technical Quality Control Personnel specific to document management QC within the TMF
• Single Point of Contact to the CTT for their assigned trials
• Provide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table of Content)
• Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions
• Proactively “pull” information during the set-up, execution, and close-out phases from accountable CTT members
• Participate in CTT meetings as needed, responsible for the training of CTTs on TMF and implementation of best practices within CTTs
• Monitor the CTT compliance with TMF process within a trial in a timely manner
• Accountable for generating and managing the TMF Filing plan and TMF QC Reports
• Contact point to secure access to eTRAC system
• Serve as Subject Matter Expert on TMF training materials, processes and tools (eg. Clinical Document Management system, user Manuals for eTRAC)
• Participate and/or may lead some meetings related to TMF processes and trainings (eg TMF QC Compliance Review Meeting)
• As a TMF QC Management & Oversight representative, may participate in global cross-functional business process performance or clinical development improvement initiatives.
• Participate in the on-boarding, mentoring and training of new staff

Key Performance Indicators:

• Timely, accurate and complete TMF Table Of Content according to trial timelines: Ready to Initiate Site (RIS); Close Out Visit (COV); End Of Trial (EoT)

Job Dimensions:

• Number of associates; Direct – 0. Indirect 5 – 15
• Financial Responsibility – None
• Impact on the organization: Accurate and complete program/trial information in Document Management System according to established timelines allowing for Increased quality of Trial Master Files (TMF), decreased audit/inspection findings and Increased compliance with TMF SOP/training, and GCP

Ideal Background:

• Experience in cross-functional, multicultural and international clinical trial teams; able to work independently
• Fluent written and oral English
• Ability to lead globally distributed matrixed teams
• Good knowledge of clinical development process, regulatory requirements and GCP. Novartis experience in these areas is preferred.
• Excellent understanding of system data structures and Clinical Document Management System functionality
• Ability to learn new systems readily
• Strong computer skills (EXCEL, MS Word) required
• Excellent attention to accuracy and details
• Excellent communication, organization and tracking skills
• Strong operational skills and demonstrated ability to meet timelines
• Proven networking skills and ability to train colleagues

Education:

• Bachelor’s degree in life science/healthcare is required with minimum 4 years’ experience in clinical operations and / or clinical systems management or Associate degree required with minimum 6 years’ experience in clinical operations and / or clinical systems management

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.