Overview
Provide oversight and leadership to Senior Global Trial Managers (SGTMs) for project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Work with Clinical teams to leverage deep therapeutic expertise and IQVIA solutions to drive operational excellence and strategic leadership with our customers. Direct and manage an assigned team of clinical leads who lead or support studies or programs to ensure quality, time and budget deliverables are met to the Sponsor’s satisfaction and in accordance with Standard Operating Procedures (SOPs), policies and practices. Ensure Clinical leads are trained and individual development is aligned and in place to meet project and organizational needs. Attract, develop and retain talent.
Essential Functions
* Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans). Ensure all Clinical Leads (CLs) obtain Fundamental GCP accreditation during a two year cycle.
* Actively engage with SGTMs to review project performance and deliverables. Address performance issues and/or escalations by creating action/recovery plans. Ensure compliance to the CL metrics dashboard of all direct reports. Foster an environment where lessons learned are shared within the team.
* Ensure compliance with the overall Risk Management process including risks escalating into issues. Identify risks that can lead to process improvement/standardization across the organization.
* Ensure compliance with quality management processes that apply to all projects. Support quality initiatives and ensure quality metrics are met at all times.
* Mentor SGTMs to manage clinical aspects of project finances, understand the scope of clinical delivery, create plans to deliver against this scope, monitor and manage changes against baseline and identify additional service opportunities or out of scope work.
* Coach SGTMs to identify Out of Scope items, discuss impact and remediation plans; promote proactive milestone risk identification.
* Review project-level clinical metrics with SGTMs to ensure data accuracy. Support SGTMs during Project Review Meetings. Ensure compliance to all critical data fields within Project Management systems/trainers. Coach SGTMs on running and reviewing various project reports.
* Resourcing and talent planning of the SGTM team. Manage the team at project level to deliver the project through high-quality operational plans, guidance and project-related trainings.
* Conduct progress reviews and evaluations and create contingency plans to mitigate project, program-level and enterprise risks.
* Mentor SGTMs for further development and ensure adherence to Individual Development Plans.
Qualifications
* Bachelor's Degree in life sciences or related field required.
* Requires 10 years of clinical research experience including 6 years leadership experience, multi-regional and global focus or equivalent combination of education, training and experience.
* Broad management knowledge to lead cross-regional teams and influence others outside of own job area regarding policies, procedures, and goals.
* Knowledge of clinical trials with deep understanding of GCP, ICH guidelines and regulatory environment; strong understanding of the clinical research industry.
* People management: proven ability to manage a team in a global environment, provide direction, delegate, mentor, coach, recruit and retain staff of high caliber.
* Collaboration: ability to work across geographies with awareness of cultural differences; establish and maintain effective working relationships with coworkers, managers and clients.
* Leadership: ability to manage competing priorities, excellent customer service skills, aptitude to understand customer needs, negotiations, good judgment and decision making.
* Organization: strong presentation, organizational and problem-solving skills; adaptability and continuous learning.
* Communication: excellent communication skills, including English proficiency.
* Results-oriented with ability to deliver to quality and timeline metrics.
* IT Skills: strong software and computer skills, including Microsoft Office.
* IQVIA Core Competencies: Client Focus, Collaboration, Communication, Innovation, Ownership.
IQVIA is a leading global provider of clinical research services, with a focus on accelerating development and improving patient outcomes. Learn more at https://jobs.iqvia.com
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