Senior Data Team Lead, home-based in South Africa

IQVIA; Bloemfontein; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A clinical research organization is seeking an experienced professional for a Data Management role in Bloemfontein. You will lead data management deliverables for multiple global studies, ensuring compliance with regulations and excellent service delivery. The ideal candidate has a Bachelor's Degree and extensive experience in data management, project leadership, and excellent communication skills. Join us to help improve patient outcomes globally.

Qualifications

• 7 years direct Data Management experience including 5+ years as a CDM project lead.
• Comprehensive understanding of the clinical drug development process.
• Ability to establish and maintain working relationships with stakeholders.

Responsibilities

• Serve as primary contact for customer on data management deliverables.
• Manage multiple large studies or programs of studies.
• Provide leadership and senior support to teams on large global programs.

Skills

Expert data management skills

Project management skills

Excellent communication and interpersonal skills

Organizational and problem-solving skills

Ability to work independently

Education

Bachelor’s Degree in health, clinical, biological or mathematical sciences

Job description

RESPONSIBILITIES

• Serve as primary point of contact 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 programs 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
• Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues
• Ensure appropriate resources are assigned to meet project deliverables
• Create and/or review and sign-off on all data management plan (DMP) documents
• Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Independently manage SOW/budget
• Independently bring process improvements and solutions to the CDM team/CDM department
• Lead a focus team or global or local best practice team
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 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)
• 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 co-workers, managers and customers

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
• Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

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 IQVIA jobs page.