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 deliverables
• Manage 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 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 CRO 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
• 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 data managers, vendors, internal team members for resolution
• 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/program/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

• Serve 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 Req
• 5 years of direct Data Management experience with 3 or more years as a CDM project lead Preferred
• Previous 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

• Client Management: Serve as primary point of sponsor 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/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 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 CRO 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
• 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 data managers, vendors, internal team members for resolution
• 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/program/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
• Serve as Project Manager for single service DM projectsPerform other duties as directed by the functional manage