Associate Clinical Lead Director

IQVIA•Durham, NC

17h

About The Position

Job 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 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 SGTMs to review project performance and deliverables. Address performance issues and/or escalations by working 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 SGTMs on identification of risks that can lead to processes improvement/standardization across the organization. Ensure compliance to 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, Support to understand the scope of clinical delivery and create plans to deliver against this scope and to 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 proactively suggest remediation plans when considering risks/delays and to determine appropriate action. Discuss and promote proactive identification of milestone risks by SGTMs Actively review project level clinical metrics with SGTMs to ensure compliance and accuracy of data. Support SGTMs during Project Review Meetings . Ensure compliance to all critical data fields within Project Management systems/ applicable trackers. Coach SGTMs on running and reviewing various project reports Resourcing and Talent planning of the SGTM team. Manage the team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance as well as project related trainings. Conduct progress reviews and evaluations in addition to create contingency plans to mitigate project, program-level and enterprise risks. Mentor SGTMs for further development and ensure they follow an Individual development plan.

Requirements

Bachelor's Degree in life sciences or related field required Req
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.
Requires broad management knowledge to lead cross-regional 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 to establish and maintain effective working relationships with coworkers, managers and clients.
Leadership - Ability to successfully manage competing priorities. Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions. Good judgment and decision making skills.
Organization - Strong presentation skills. Strong organizational and problem-solving skills. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. Strong understanding of other IQVIA functions and their inter-relationship with Project Support Units.
Communication - Excellent communication skills, including good command of English language.
Results Oriented - Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
IT Skills - Strong software and computer skills, including Microsoft Office applications.
IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation, Ownership).

Responsibilities

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 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.
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 SGTMs to review project performance and deliverables.
Address performance issues and/or escalations by working 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 SGTMs on identification of risks that can lead to processes improvement/standardization across the organization.
Ensure compliance to 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,
Support to understand the scope of clinical delivery and create plans to deliver against this scope and to 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 proactively suggest remediation plans when considering risks/delays and to determine appropriate action.
Discuss and promote proactive identification of milestone risks by SGTMs
Actively review project level clinical metrics with SGTMs to ensure compliance and accuracy of data.
Support SGTMs during Project Review Meetings .
Ensure compliance to all critical data fields within Project Management systems/ applicable trackers.
Coach SGTMs on running and reviewing various project reports
Resourcing and Talent planning of the SGTM team.
Manage the team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance as well as project related trainings.
Conduct progress reviews and evaluations in addition to create contingency plans to mitigate project, program-level and enterprise risks.
Mentor SGTMs for further development and ensure they follow an Individual development plan.