Senior Data Team Lead, FSP

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

Job summary

A leading global clinical research company in Bloemfontein is seeking a Data Manager to oversee multiple studies and lead negotiations with customers. The ideal candidate will have at least 7 years of data management experience, including leadership roles in global trials. This position requires strong communication skills and project management expertise to ensure successful delivery of data management services.

Qualifications

• 7 years of direct Data Management experience, including 5 years as a project lead.
• Proven competence in managing delivery of multiple global trials.
• Understanding of clinical drug development processes.
• Knowledge of Good Clinical Practices and relevant regulatory guidelines.

Responsibilities

• Serve as primary contact for customer on data management deliverables.
• Manage multiple large studies or programs.
• Provide leadership and senior support to team leaders.
• Lead negotiations with customers regarding timelines and resources.
• Ensure milestones meet timelines and quality deliverables.

Skills

Data management

Project management

Negotiation skills

Communication skills

Problem-solving skills

Organizational skills

Teamwork

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 actionsServe 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
• Working hours to accommodate global client and projects

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 https://jobs.iqvia.com