Job Overview
Independently oversee delivery of data management services from CROs for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Ensure comprehensive data management expertise in Clinical Data Management (CDM) team to ensure high quality data management support. 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 sponsor for customer on data management deliverablesManage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/program of global studies.Provide leadership and senior support to DTLs on multiple large global studies/program 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 expertiseLead direct negotiations with customer, e.g., timelines, financial, process, resources.Maintain strong customer relationshipsEnsure open communications with customer and IQVIA management to independently manage and meet contractual obligationsService Management:Meet with CRO 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 holdersIndependently manage DM service delivery with comprehensive DM process and technical expertise in executing projectsServe as the escalation point for unresolved data issuesIndependently work with data managers, vendors, internal team members for resolutionReview 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/program/customer account. Ensure timely follow-up and resolution of compliance issuesServe as Subject Matter Expert (SME)Provide leadership and expertise in a specific CDM task or technologyServe as customer site lead for one or more customersServe as Project Manager for single service DM projectsPerform other duties as directed by the functional manager

Qualifications

Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field Req5 years of direct Data Management experience with 3 or more years as a CDM project lead PreferredPrevious experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 100 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 clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. 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. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $86,800.00 - $217,100.00. 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.