Clinical Data Management Lead

6 days ago

Durham, North Carolina, United States IQVIA Full time

Job Overview

The Data Management Team Lead will be responsible for managing the end-to-end delivery of data management services for single/multi-service projects with minimal guidance. This includes ensuring quality deliverables are met on time and within budget, to customer satisfaction. The successful candidate will provide comprehensive data management expertise to the Clinical Data Management (CDM) team to provide high-quality data management products that meet customer needs.

Key Responsibilities

  • Manage project planning, execution, and close-out; financial management; communications; and milestone deliverables.
  • Provide leadership to the team in the areas of project planning, execution, and close-out.
  • Perform role of Data Team Lead (DTL).
  • Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Client Management

  • Serve as primary point of contact for customer on 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.
  • Maintain strong customer relationships.
  • Ensure open communications with customer and IQVIA 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 stakeholders.
  • 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, 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 plan.
  • Identify any service and quality issues with agreed-upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve.
  • Track service performance and provide leadership to identify root causes of issues and implement remedial actions.
  • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables.
  • Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution.
  • Maintain internal tracking databases and systems.

Financial Management/Business Development Support

  • Ensure service and quality meet agreed-upon timelines and deliverables in contract/SOW.
  • Manage SOW/budget.
  • Review financial reports on a monthly basis and participate in project reviews as requested.
  • Identify out-of-scope tasks and track change orders to completion.
  • Participate in and support RFP process (review RFP documents, pricing, attend bid defense).

Other

  • Provide input on DM process improvements or project solutions to CDM team/CDM department.
  • Provide input on the development and implementation of a new technology or tool.
  • Participate in a focus team or global or local best practice team.
  • Perform other duties as directed by functional manager(s).

Qualifications

  • Bachelor's Degree in Health, clinical, biological, or mathematical sciences, or related field.
  • 5 years direct Data Management experience, including 3 or more years as a CDM project lead. Equivalent combination of education, training, and experience.
  • Previous experience and proven competence in managing study delivery through full DM life cycle (at least 1 medium Phase III).
  • Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology.
  • Knowledge of operating procedures and work instructions and the ability to apply them in practice.
  • Knowledge of Good Clinical Practices and applicable regulatory guidelines.
  • Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs.
  • Comprehensive understanding of clinical drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and customers.

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