Offer summary

Qualifications:

Bachelor’s Degree in health, clinical, biological or mathematical sciences, or related field., 5+ years of direct Clinical Data Management experience in CRO or pharmaceuticals industry, including 3+ years as a CDM project lead., Knowledge of Good Clinical Practices and relevant regulatory guidelines., Excellent communication, interpersonal, and teamwork skills..

Key responsibilities:

Manage end-to-end delivery of data management services for projects, ensuring quality deliverables on time and within budget.

Serve as the primary point of contact for customers on clinical data management deliverables.

Establish strong communications with Data Operations team and stakeholders to meet project milestones.

Implement proactive quality management plans and track service performance across multiple projects.

Job description

JOIN US ON OUR EXCITING JOURNEY!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

This Clinical Data Team Lead will be responsible for managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Direct the team in areas of project planning, execution and close-out, financial management, communications and milestone deliverables. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Responsibilities

Client Management

Serve as primary point of contact for customer on clinical data management deliverables
Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resource
Maintain strong customer relationships
Ensure open communications with customer and Quintiles management to manage and meet contractual obligations

Service Management

Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
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
Serve as the escalation point for unresolved data issues; work with client data managers, vendors, and internal team members for resolution
Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
Create and/or review and sign-off on all data management plan (DMP) documents
Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions
Serve as Subject Matter Expert (SME)
Provide leadership and expertise in a specific CDM task or technology
Maintain internal tracking databases and systems

Qualifications

Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
5+ years direct Clinical Data Management experience in CRO or pharmaceuticals industry , including 3+ years as a CDM project lead; or equivalent combination of education, training and experience
Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)
Previous experience of handling customer negotiations
Knowledge of Good Clinical Practices and relevant regulatory guidelines
Excellent communication, interpersonal, customer service, and teamwork skills
Comprehensive understanding of clinical drug development process
Ability to establish and maintain effective working relationships with co-workers, managers and customers

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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