Global Clinical Lead - Remote, United Kingdom - IQVIA

IQVIA
IQVIA
Verified Company
Remote, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Provide oversight and leadership to Clinical Leads (CL) for project productivity, delivery and quality resulting in strong financial performance and customer satisfaction.

Work with Clinical Lead (CL) teams to focus on leveraging 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 make sure 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 (International Conference on Harmonization (ICH)Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). Ensure all Clinical Leads (CLs) obtain Fundamental Good Clinical Practices (GCP) accreditation during a two year cycle.
  • Actively engage with Clinical Leads (CLs) to review project performance and deliverables. Address CL performance issues and/or escalations by working with Clinical Leads (CLs) to create action/recovery plans. Ensure compliance to the Clinical Leads (CL) metrics dashboard of all direct reports. Foster an environment where lessons learned are shared within the team.
  • Ensure compliance on the overall Risk Management process including risks that are escalating into issues. Work with Clinical Leads (CLs) on identification of risks that can lead to processes improvement/standardization across the organization.
  • Mentor Clinical Leads (CLs) to manage clinical aspects of Project Finances including Estimate at Completion (EAC). Support Clinical Leads (CLs) to understand the scope of clinical delivery and create plans to deliver against this scope and to monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
  • Support Clinical Leads (CLs) in baselining and updating Project Schedules, to align with the stage of the project and ensure Project Schedules are published on a timely basis for actual dates and changes in forecasted days.
  • Coach Clinical Leads (CLs) to identify Out of Scope items, discuss impact and proactively suggest remediation plans when considering risks/delays and present these to Project Leads to determine appropriate action. Discuss and promote proactive identification of milestone risks by Clinical Leads (CLs).
  • Actively review project level clinical metrics with CLs to ensure compliance and accuracy of data. Support CLs during Project Review Meetings. Ensure compliance to all critical data fields within Project Management systems. Coach Clinical Leads (CLs) on running and reviewing various project reports.
  • Resourcing and Talent planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of highquality operational plans and guidance as well as project related trainings.
  • Conduct progress reviews and evaluations in addition to create contingency plans to mitigate project, programlevel and enterprise risks.
  • Mentor Clinical Leads (CLs) for further development and ensure they follow an Individual development plan.

Qualifications:


  • Bachelor's Degree Bachelor's Degree in life sciences or related field required Req
  • Requires 10 years of clinical research experience including 6 years leadership experience, multiregional and global focus or equivalent combination of education, training and experience.
  • Requires broad management knowledge to lead crossregional teams, and well as the ability to influence others outside of own job area regarding policies, procedures, and goals.
  • Knowledge of clinical trials
  • In depth knowledge and skill in applying, applicable clinical research regulatory requirements i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Strong understanding of the Clinical Research Industry and the relevant environments in which it operates.;


  • People Management

  • Proven ability to manage a team and work alongside others in a global environment to deliver results whilst meeting quality and timeline metrics. Provides others with a clear direction, delegates work appropriately and fairly, motivates and empowers others, monitors/manages performance and provides feedback and coaching, recruits, develops and retains staff of a high caliber. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues


  • Collaboration

  • Ability to work across geographies displaying high awareness and understanding of cultural differences. Ability
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