Snr Quality Review Specialist

IQVIA Argentina; Bloemfontein; On-site; ZAR 1,000,000 - 1,600,000; 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. You will lead the CDM team, manage customer relationships, and drive data management through full lifecycle with a focus on quality control and process improvement.

The role requires a Bachelor's degree in clinical, biological or mathematical sciences (or nursing) and 5+ years of experience managing multiple data management projects, including negotiations with

Qualifications

• Bachelor's degree in clinical, biological or mathematical sciences, or nursing qualification.
• 5+ years of experience managing multiple data management projects through full lifecycle, including large trials.

Responsibilities

• Act as Data Team Lead (DTL) on global trials and lead CDM team.
• Manage CDM customer relationships and lead negotiations on timelines and budgets.
• Provide leadership, mentoring and training to the CDM team and develop data management solutions.
• Oversee data management through full lifecycle and ensure quality control and SOP compliance.
• Coordinate resources, timelines, and budgets; manage vendor and scope-of-work.
• Present at conferences or publish articles to share CDM expertise.

Skills

Leadership

Data management

Project management

Client negotiations

Mentoring

Communication

Education

Bachelor's degree in clinical, biological or mathematical sciences, or nursing qualification

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.