Independently manage 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. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

　　Essential Functions

　　Client Management: 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/programme of global studies Provide leadership and senior support to DTLs on multiple large global studies/programme 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.

　　Maintain strong customer relationships

　　Ensure open communications with customer and IQVIA management to independently 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

　　Provide training and development on data management expertise to junior team members

　　Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders

　　Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects

　　Serve as the escalation point for unresolved data issues

　　Independently work with client data managers, vendors, internal team members for resolution

　　Ensure appropriate resources are assigned to meet project deliverables

　　Create and/or review and sign-off on all data management plan (DMP) documents

　　Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW

　　Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions

　　Continuously look for opportunities to improve service

　　Develop and work with team to implement plan to re-organise and drive change (possibly across a customer account)

　　Ensure timely follow-up and resolution of compliance issues

　　Serve as Subject Matter Expert (SME)

　　Provide leadership and expertise in a specific CDM task or technology

　　Serve as customer site lead for one or more customers

　　Train and mentor junior DTL staff in DM expertise

　　May coordinate the work of more junior DTL staff

　　Independently maintain internal tracking databases and systems

　　Financial Management/Business Development Support:

　　Independently 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 pricing discussions across customer account

　　Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing

　　Independently support RFP process (review RFP documents, pricing, attend bid defense)

　　Independently bring process improvements and solutions to the CDM team/CDM department

　　Lead a focus team or global or local best practice team

　　Communicate lessons learned and/or present in CDM workshop(s)

　　Manage the development and implementation of new technology or tool

　　Present at professional conferences and/or publish articles in professional journals

　　Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

　　Perform other duties as directed by the functional manager

　　Qualifications

　　Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field Req

　　5 years of direct Data Management experience with 3 or more years as a CDM project lead Pref

　　Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients).

　　Demonstrated expert data management skills and advanced 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).

　　Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently.

　　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 relevant regulatory guidelines.

　　Excellent communication, interpersonal, customer service, and teamwork skills.

　　Excellent organizational and problem-solving skills. Excellent project management skills.

　　Ability to work independently. Comprehensive understanding of clinical drug development process.

　　Ability to establish and maintain effective working relationships with coworkers, managers and customers.

　　Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients).

　　Demonstrated expert data management skills and advanced 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).

　　Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently.

　　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 relevant regulatory guidelines.

　　Excellent communication, interpersonal, customer service, and teamwork skills.

　　Excellent organizational and problem-solving skills. Excellent project management skills.

　　Ability to work independently. Comprehensive understanding of clinical drug development process.

　　Ability to establish and maintain effective working relationships with coworkers, managers and customers.

　　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

　　We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

　　IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

　　The potential base pay range for this role, when annualized, is $107,000.00 - $160,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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