Snr Quality Review Specialist

Posted Yesterday
Be an Early Applicant
3 Locations
In-Office
Senior level
Healthtech
The Role
Leads clinical data management operations across global clinical trials and central laboratory studies from startup through database lock. Oversees teams, timelines, budgets, quality, resources, customer negotiations, and project delivery. Provides technical expertise, process improvement, mentoring, quality control, SOP development, and technology implementation. Requires substantial experience managing multiple complex studies, large patient populations, and customer-facing negotiations.
Summary Generated by Built In

Job Overview

Principal Data Manager position is to oversee data operations tasks for a team of data managers from study start-up to database lock, to produce a clean and analyzable database.

Essential Functions

• Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
• Provide leadership to CDM team.
• Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.
• Provide marketing capabilities presentations and business development presentations. . Or serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task.
• Serve as back-up for Data Operations Coordinator or Data Team Lead
• Provide leadership to Operations team
• Provide technical expertise. Or serve as a Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology. Manage delivery of projects through full data management process life-cycle.
• Management of:
• Project timelines
• Quality issues
• Resource management
• SOW (scope of work) / budget. Provide justification for customer negotiations. May serve as Project Manager for single service data management projects. Manage comprehensive data management tasks pertaining to the documented project specifications. Manage comprehensive quality control procedures. Provide data management expertise and data management process improvement to CDM management. Mentor other team members in training and developing data management expertise. Independently bring project solutions to the CDM team and the CDM Department. Manage a focus team or a best practice team. Manage the development and implementation of new technology/tool. Present at professional conferences and/or publish articles in professional journals. Provide CDM with technical expertise. Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. Perform other duties as directed by the functional manager. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM and project teams."

Qualifications

• Bachelor's Degree clinical, biological or mathematical sciences, or related field or nursing qualification Req
• 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients, and including experience handling customer negotiations (e.g. bid defense meetings). Equivalent combination of education, training and experience.
• Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent experience and organizational, communication, and demonstrated expert data management skills. Comprehensive understanding of clinical drug development process (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Excellent experience and organizational, communication, and demonstrated expert data management skills. Comprehensive understanding of clinical drug development process (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Skills Required

  • Bachelor’s degree in clinical, biological, or mathematical sciences, a related field, or a nursing qualification
  • At least 5 years of relevant experience
  • Proven competence managing multiple projects through the full clinical data management study lifecycle
  • Experience managing large clinical trials involving more than 1,000 patients
  • Experience handling customer negotiations, including bid defense meetings
  • Thorough knowledge of clinical data management processes
  • Specialized data management expertise, such as therapeutic data, SAE reconciliation, central laboratory data, or new technology
  • Knowledge of operating procedures and work instructions, with the ability to apply them
  • Strong organizational, communication, and data management skills
  • Comprehensive understanding of the clinical drug development process
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients

IQVIA Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.

  • Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
  • Retirement Support — Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
  • Leave & Time Off Breadth — Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.

IQVIA Insights

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The Company
HQ: Durham, NC
61,500 Employees
Year Founded: 2016

What We Do

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.

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