Snr Quality Review Specialist

IQVIA; Bloemfontein; On-site; ZAR 1,415,000 - 1,729,000; Full time

Job summary

IQVIA is seeking a Principal Data Manager to oversee data operations for a team of data managers from study start-up to database lock, delivering a clean, analyzable database. The role drives leadership for the CDM team, manages customer relationships, and ensures delivery across full data management lifecycles.

The position requires extensive data management expertise, experience with large trials, and strong negotiation and project management skills, within a global clinical research framework.

Qualifications

• 5 years experience delivering multiple data management projects.
• Experience with large trials (>1000 patients) and customer negotiations.
• Thorough knowledge of data management processes and SOPs.

Responsibilities

• Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ central laboratory studies.
• Provide leadership to CDM team.
• Manage CDM customer relationships and lead negotiations on timelines and budgets.
• Serve as Data Operations Coordinator (DOC) for global trials or lead a DM Task as needed.
• Back-up for Data Operations Coordinator or Data Team Lead as required.
• Provide leadership to Operations team and SME expertise in CDM tasks.
• Manage delivery of data management projects through the full lifecycle.
• Oversee project timelines, quality issues, resources, and budgets; develop SOPs and best practices.

Skills

Data management

Project management

Leadership

Customer negotiations

Stakeholder management

Data quality

Education

Bachelor's Degree in clinical, biological or mathematical sciences

Nursing qualification

Job description

• Bloemfontein, South Africa
• Bellville, South Africa
• Centurion, South Africa

Full time

R1571732

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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