Snr Quality Review Specialist

IQVIA Argentina; Bellville; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

IQVIA is seeking a Principal Data Manager to oversee data operations from study start-up to database lock, delivering a clean, analyzable database. You will lead the CDM team across multiple global trials, manage customer relationships, and drive data management lifecycle excellence.

The role requires extensive experience in data management, leadership, and capability to mentor staff while delivering high-quality outcomes for complex studies and budgets.

Qualifications

• Bachelor's degree in clinical, biological or mathematical sciences, or related field.
• 5+ years of experience delivering multiple data management projects through full study life-cycle.
• Experience handling customer negotiations (e.g. bid defense meetings).

Responsibilities

• Lead a Data Management team on a program of 6–10 global trials.
• Provide leadership to the CDM team.
• Manage CDM customer relationships and negotiate timelines and budgets.
• Oversee data management projects through full data lifecycle.
• Mentor team members and drive process improvements.
• Develop and present data management solutions and SOPs.

Education

Bachelor's Degree in clinical, biological or mathematical sciences, or related field

Job description

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.