TMF Site File Delivery Manager (Home based)- Iqvia Biotech - in Bucuresti

IQVIA Biotech is a unique division specializing in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.We are actively looking for a Service Delivery Manager:Responsible for the oversight of service delivery for studies managed in Site File Operations (SFO) by supporting the project teams to ensure quality and regulatory compliance of the Investigator Site Files (ISF) process at IQVIA Biotech. Provide oversight to the project teams ensuring activities are in line with contracted scope; monitor the resourcing requirements of assigned studies; review financial reports to track execution towards proposed budget; and, support the efforts of SFO Team Members, ensuring clear client and internal team communication. Oversees the team to ensure site level 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. Provide mentorship to SFO team members, providing support to identify and mitigate risks that may arise during the study. Support and coach the SFO team through project level problem solving. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:• Supports the SFO team members in the maintenance phase (from site activation through close out), serving as a point of escalation for Project Team members, if needed.• Oversees key accounts and portfolios by assuming SFO Service study oversight responsibilities and developing strategies to support the team to deliver execution of study timelines, corporate and department quality metrics, resource management, performance oversight, and team collaboration activities• Communicates challenges and concerns to Site File Operations Line and Department Management, as well as Project Management• Involved in oversight of resourcing requests across portfolios and projects. Liaises with SFO Line Managers regarding resourcing needs and challenges, performance issues or training requirements to ensure necessary resources are assigned to their projects • When an Amendment Lead is not assigned to a project, supports the team to drive amendment deliverables as outlined in study plans and per region, as applicable. When an Amendment Lead is assigned, support the Amendment lead as needed.• Oversees and supports staff on their projects to ensure that work is completed efficiently and effectively. Mentors employees as needed in the implementation of their tasks, navigating study challenges and responsibilities within their job description.• Evaluates completeness and quality metrics for site level documentation of their assigned studies and works with teams to bring metrics in line with IQVIA Biotech expectations. • Ensures site-level related study tracking is quality checked on a regular basis and maintained to departmental standards and IQVIA Biotech SOP/WPs.• During the maintenance phase, runs reports to ensure that all IRB and Ethics approvals are tracked in a timely manner, and kept current in accordance with site, country and study requirements and timelines, as applicable. Work with the appropriate team members if any have lapsed.• Maintains contact, as needed, with Project Managers, Clinical Trial Managers and other functional study leads to ensure overall service delivery of the project• Participates in financial and/or resource forecasting; ensures financial deep dives are completed on studies and out of scope activities are alerted to Management, PM and study team to ensure that such activities do not begin until authorization by PM and Management has been provided.• Assures team members understand budgets for the studies they are working on and maintain accountability for notifying Project Managers when additional activities may cause budget overburn. Ensures SFO teams are identifying, documenting, and raising changes in scope for file maintenance activities to the PM.• Liaises with Department Quality Manager and works to prepare the SFO study teams for upcoming audits by evaluating quality metrics and liaising with Leads/Specialists/Associates for any outstanding items. Attends audits, as applicable. • Ensures the assigned SFO Lead assigned to the study are assuring that Study Management Plans are aligned for SFO expectations and updated as necessary for ongoing updates/changes, through touchbase with Leads and spot checks of Study Plans.• Identifies areas of process improvements and coordinates with SFO global management team to resolve issues; includes supporting process development, strategizing study management improvements and updates to trainings and/or SOP/WP.• Collaborates with line management when staff performance issues are identified on a study and provides support to line management to resolve the staff level issues. • Supports the SFO Lead with interactions with the Sponsor, attending meetings if required• Assures that the appropriate IQVIA Biotech and/or sponsor SOPs are followed• Performs other duties as required to ensure study compliance, completeness and staff support.KNOWLEDGE, SKILLS & ABILITIES:• Demonstrated ability in the leadership of a team of individuals in document management and study management processes• Extensive knowledge of clinical research process and medical terminology • 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 and across clients• 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 • Strong understanding of project financials & applicable tools • Extensive knowledge of eTMF systems#LI-AP22IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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