Vacant Positions at IQVIA

Main responsibilities

• Provide leadership and vision to the team
• Manage and deliver several large scale, high complexity/non-standard aspect studies across a range of sponsors and Therapeutic areas
• Manage sponsors at both Study and Programme Level
• Manage delivery of areas requiring specific expertise (e.g Process, Finance)
• Ensure milestones meet timelines and quality deliverables
• Provide project management expertise working with customer data managers, key decision makers and internal team members to manage continuous process improvements and provide technical expertise
• Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
• Provide input for and perform direct negotiations with customer
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Support DM service delivery with comprehensive DM process and technical expertise in executing projects
• Create and/or review and sign-off on all data management plan (DMP) documents
• Track service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
• Maintain internal tracking databases and systems

Minimum Education & Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 5 years direct Data Management experience, including 3 or more years as a Clinical Data Management project lead is preferred
• Ability to maintain strong customer relationships

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RESPONSIBILITIES

• Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer
• Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
• Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications
• May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs
• May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
• Deliver regulatory training/presentations as required, internally or externally
• May mentor junior colleagues and engage in department knowledge sharing
• May perform additional tasks as deemed appropriate by Line Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development
• Demonstrates comprehensive regulatory/technical expertise
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
• Strong ownership and oversight skills
• Demonstrated skills in chairing meetings and working on initiatives
• Ability to work on several projects, retaining quality and timelines and can prioritize workload
• Ability to propose revisions to SOPs or suggest process improvements for consideration
• Strong mentoring skills, helping junior colleagues and setting a positive example
• Innovative and solutions-driven
• Strong skills in establishing and maintaining effective working relationships with co-workers, managers and clients
• Strong software and computer skills, including MS Office applications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)
• EU-CTR knowledge & experience
• Global CTA submission experience

PHYSICAL REQUIREMENTS

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Travel might be required

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• Build a rewarding career in life sciences consulting and forge your own path. Partner with collaborative teams and leaders across unique projects and geographies, delivering innovative solutions to the most complex healthcare problems along the way. Working at IQVIA means changing outcomes for patients one data set, product offering and innovative solution at a time.
• As a Consultant at IQVIA, you'll have the opportunity to grow your career and explore opportunities in brand and integrated research solutions, go-to-market strategy, commercial excellence, real world data, financial investor consulting and more.