Clinical Data Manager/Data Team Lead (REMOTE)

**PURPOSE** :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, 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**JOB DESCRIPTION:**+ Participate in and support RFP process (review RFP documents, pricing, attend bid defense)+ Independently bring solutions to the CDM team/CDM department+ Lead and/or participate in a focus team or global or local best practice team+ Communicate lessons learned and/or present in CDM workshop(s)+ Participate in the development and implementation of new technology or tool+ Present at professional conferences and/or publish articles in professional journals+ Provide review and input on developing, revising, and maintaining core operating procedures and work instructions+ Perform other duties as directed by the functional manager**RESPONSIBILITIES:**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+ Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources+ Maintain strong customer relationships+ Maintain the Data Management study files in the audit ready condition.+ Ensure open communications with customer and IQVIA management to manage and meet contractual obligationsService 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, 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+ Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW+ Implement proactive quality management plans across multiple projects/programs.

Track service performance and provide leadership to identify root causes of issues and implement remedial actions+ Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organize and drive change across multiple projects/programs (with minimal support)+ 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+ Train and mentor junior DTL staff in DM expertise.

May coordinate the work of more junior DTL staff+ Maintain internal tracking databases and systemsFinancial Management/Business Development Support:+ Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (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+ Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing+ Independently bring solutions to the CDM team/CDM department+ Lead and/or participate in a focus team or global or local standard methodology team+ Communicate lessons learned and/or present in CDM workshop(s)+ Participate in the development and implementation of new technology or tool+ Present at professional conferences and/or publish articles in professional journals+ Perform other duties as directed by the functional manager**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:**+ 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 GCP and relevant regulatory guidelines+ Excellent communication, interpersonal, customer service, and teamwork skills+ Excellent project management skills+ Excellent organizational and analytical skills+ Comprehensive understanding of clinical drug development process+ Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)**Required Education and Experience:**+ Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related discipline, and 5 years direct Data Management experience, including 3 or more years as a CDM project lead; or equivalent combination of education, training and experience+ Previous experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programs)+ Previous experience of handling customer negotiations+ 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 GCP and relevant regulatory guidelines+ Excellent communication, interpersonal, customer service, and teamwork skills+ Excellent project management skills+ Excellent organizational and analytical skills+ Comprehensive understanding of clinical drug development process+ Occasional travel is requiredAt IQVIA, 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.

The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

Learn more at jobs.iqvia.com .All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.IQVIA, Inc.

provides reasonable accommodations for applicants with disabilities.

Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.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.EEO Minorities/Females/Protected Veterans/Disabled