Senior Data Team Lead, Clinical Data Management - Home based, Europe - Real World Evidence
IQVIA™ Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers and patients. Our unique approach is in the industry defines the way companies develop and apply real-world evidence for healthcare decision making.
RWE Data Management is at the heart of our study delivery and responsible for ensuring high-quality study databases to help our customers generate real world evidence. RWE Data Management is shaping and responding to the changing way real world research is conducted. This includes management of data quality, reliability and integrity by study design and purpose. The team is adapting to the increase in data variety across EDC technologies, directly from patients, through decentralization of clinical research and modular studies with data capture from a blend of sources.
PURPOSE OF THE ROLE
As a Clinical Senior Data Team Lead(Sr DTL) you will manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to meet client needs in the exciting and growing Real World Environment. In addition, you will provide comprehensive data management expertise to the Clinical Data Management (CDM) team to provide high quality client driven data management products. You will also provide leadership and vision to the team in the areas of project planning, execution and close-out.
Please only apply if you meet the candidate criteria detailed below. Applications must be in English.
REQUIRED EDUCATION KNOWLEDGE, SKILLS AND EXPERIENCE
- Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
- Minimum of 7 years direct Clinical Data Management experience, including 5 or more years as a Clinical Data Management project lead
- Demonstrable expert CDM skills and thorough knowledge of the CDM processes (e.g., therapeutic area, SAE reconciliation, external data vendor reconciliation, management of local laboratory data and/or new technology)
- Proven experience and competence in managing delivery of multiple and complex studies/projects/programs through full CDM lifecycle
- Previous experience of handling customer negotiations
- Excellent communication, interpersonal, customer service, and teamwork skills
- Fluency in English written and verbal
- Serve as primary point of contact for customer on data management deliverables
- Manage multiple large studies or program of studies (possibly global)
- Provide leadership and senior support to DTLs on multiple large global studies/programs of global studies
- 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
- Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
- Create and/or review and sign-off on all data management plan (DMP) documents
- Serve as Subject Matter Expert - Provide leadership and expertise in a specific CDM task or technology
- Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff
- Ensure service and quality meet agreed timelines and deliverables in contract Scope of Work (SOW)
- Implement proactive quality management plans across multiple projects/programs/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
- Serve as Project Manager for single service DM projects, including financial tracking
- Participate in and support RFP process
- Independently maintain internal tracking databases and systems
We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of Real-World Evidence in an evolving industry!
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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