Clinical Data Manager / Data Team Lead / Senior Data Team Lead (Remote)

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Posted 11 days ago United States Salary undisclosed
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Job Description

Job descriptionPURPOSE: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 documentsJOB DESCRIPTION:Participate in and support RFP process (review RFP documents, pricing, attend bid defense)Independently bring solutions to the CDM team/CDM departmentLead and/or participate in a focus team or global or local best practice teamCommunicate lessons learned and/or present in CDM workshop(s)Participate in the development and implementation of new technology or toolPresent at professional conferences and/or publish articles in professional journalsProvide review and input on developing, revising, and maintaining core operating procedures and work instructionsPerform other duties as directed by the functional managerRESPONSIBILITIES:Client Management:Serve as primary point of contact for customer on data management deliverablesProvide 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 expertiseProvide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resourcesMaintain strong customer relationshipsMaintain 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 deliverablesEstablish strong communications with Data Operations team, functional leads, project managers and all other stake holdersSupport DM service delivery with comprehensive DM process and technical expertise in executing projectsServe as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolutionWork with functional manager(s) to ensure appropriate resources are assigned to meet project deliverablesCreate and/or review and sign-off on all data management plan (DMP) documentsEnsure service and quality meet agreed upon specifications per the DMP and contract/SOWImplement proactive quality management plans across multiple projects/programs. Track service performance and provide leadership to identify root causes of issues and implement remedial actionsContinuously 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 issuesServe as Subject Matter Expert (SME)Provide leadership and expertise in a specific CDM task or technologyTrain and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staffMaintain 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/budgetReview financial reports on a monthly basis and participate in project reviews as requestedIdentify out of scope tasks and track change orders to completionServe as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicingIndependently bring solutions to the CDM team/CDM departmentLead and/or participate in a focus team or global or local standard methodology teamCommunicate lessons learned and/or present in CDM workshop(s)Participate in the development and implementation of new technology or toolPresent at professional conferences and/or publish articles in professional journalsPerform other duties as directed by the functional managerREQUIRED KNOWLEDGE, SKILLS AND ABILITIES:Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or PhysiologyKnowledge of operating procedures and work instructions and the ability to apply them in practiceKnowledge of GCP and relevant regulatory guidelinesExcellent communication, interpersonal, customer service, and teamwork skillsExcellent project management skillsExcellent organizational and analytical skillsComprehensive understanding of clinical drug development processDemonstrated 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 8 years direct Data Management experience, including 3 to 5 or more years as a CDM project lead; or equivalent combination of education, training and experiencePrevious experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programs)Previous experience of handling customer negotiationsKnowledge of Medical Terminology, Pharmacology, Anatomy, and/or PhysiologyKnowledge of operating procedures and work instructions and the ability to apply them in practiceKnowledge of GCP and relevant regulatory guidelinesExcellent communication, interpersonal, customer service, and teamwork skillsExcellent project management skillsExcellent organizational and analytical skillsComprehensive understanding of clinical drug development processOccasional 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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, 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 to arrange for such an accommodation.