Site File Operations Manager, (Europe, homebased) - Iqvia Biotech
IQVIA Holdings Inc.
Responsible for the quality and regulatory compliance of the Investigator Site Files (ISF) process at IQVIA Biotech Clinical Inc. Perform project team and line management activities, coordinate the efforts of Site File Operations Team Members and maintain clear client and internal team communication. Oversee process documentation in compliance with International Congress on Harmonization-Good Clinical Practice (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Responsible for direct line management for Site File Operations team members including resource selection and hiring performance training and oversight, timesheet review and approval and team collaboration activities.
• Oversees Site File activities in the maintenance phase and updates during weekly client teleconferences and internal team meetings as needed.
• In North America oversees the negotiation of Informed Consent Forms.
• Leads a team as they assist sites with local IRB/ethics committee submissions
• Oversees IQVIA Biotech liaison with Central IRBs/REBs/ECs, as applicable
• Manages quality and regulatory compliance documentation among investigational sites.
• Manages study timelines after site activation to close out, documents study challenges and communicates them to the, Sr. Mgr. or Associate Dir. and Project Manager.
• Oversees ongoing QC process and periodic investigator site file audits to ensure compliance with GCP and IQVIA Biotech’s standard operating procedures. Communicates directly with the site personnel, or with local CRA in various countries, as appropriate to achieve stated objectives and to ensure files are maintained in an audit ready condition at all times.
• Oversees the entry of Investigator names in Clinical Trial Management System (CTMS)
• Oversee collection and review of ongoing regulatory documents for completeness and accuracy. Responsible for assuring updates are made to CTMS if applicable.
• Assures team members understand budgets for the studies they are working on and maintain accountability for notifying Project Managers when additional activities may cause the overage on budgets.
• Maintains contact with Project Managers, Clinical Trial Managers and CRAs to obtain necessary documentation throughout the trial.
• Assures all project documentation is appropriately filed per IQVIA Biotech SOPs.
• Assures that any out of scope Site File Operations activities are alerted to Management, Project Manager and team and assures that such activities do not begin until the client provides authorization.
• Participates in financial and/or resource forecasting.
• Leads in identifying and generating changes in scope within the File Maintenance activities.
• Oversees the Regulatory Document Management Plans for ongoing changes.
• Develops/ reviews the Investigator Site File Review Plans.
• Serves as IQVIA Biotech representative in interactions with the sponsor, as appropriate.
• Participates in proposal preparation and bid defense activities as requested.
• Trains and mentors new employees in the implementation of the tasks and responsibilities within their job description.
• Serves as backup to Sr. Manager/Associate Director as requested.
• Assures that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
• Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
• Demonstrated ability in the leadership of a team of individuals in the document management process.
• Extensive knowledge of clinical research process and medical terminology including the submission process
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple competing priorities within various clinical trials.
• Extensive knowledge of current ICH GCP guidelines and applicable regulations.
• Demonstrated knowledge & involvement in audit preparation
• Ability to gain successful outcomes in areas of challenge regarding the TMF & document management
• Ability to lead staff at all levels in above activities.
• General understanding of project financials & applicable tools
• Ability to work independently, prioritize and work with a matrix team environment is essential.
• Working knowledge of Word, Excel is required.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.