Director of Post - Market Surveillance and Clinical Evaluation at Cook Medical. Leading global strategy, governance, and compliance in Post Market Surveillance and Clinical Evaluation activities.
About the role
- Associate Clinical Lead Director at IQVIA providing oversight and leadership for clinical trial managers. Ensuring project productivity, delivery, and quality while meeting regulatory compliance and organizational standards.
Responsibilities
- Provide oversight and leadership to Senior Global Trial managers 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.
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements.
- Actively engage with Senior Global Trial Managers to review project performance and deliverables.
- Address performance issues and escalations by working to create action/recovery plans.
- Ensure compliance on the overall Risk Management process including risks that are escalating into issues.
- Work with Senior Global Trial Managers 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 Senior Global Trial Managers 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 Senior Global Trial Managers to identify Out of Scope items, discuss impact and proactively suggest remediation plans when considering risks/delays and to determine appropriate action.
- 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.
Requirements
- Bachelor's Degree in life sciences or related field
- 10 years of clinical research experience including broad experience in Clinical Project Management delivery.
- At least 3 years of experience managing teams in a fast-paced work environment.
- 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.
- 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.
- 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, manages performance and provides feedback and coaching, recruits, develops and retains staff of a high caliber.
- Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal stakeholders and customers as well as negotiate solutions.
- Strong presentation skills.
- IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation, Ownership).
Benefits
- May require occasional travel within Europe and the United States
Job title
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Degree requirement
Tech skills
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