Senior Data Team Lead, Technical Design, South Africa at IQVIA

Bloemfontein, Free State, South Africa

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Clinical Research, PharmaceuticalIndustries

Requirements

Bachelor's Degree in Health, clinical, biological or mathematical sciences, or related field
3 years direct Data Management experience, including 1 or more years as a CDM project lead
Equivalent combination of education, training and experience
Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III)
Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
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 applicable regulatory guidelines
Good communication skills
Technically logical thinker
Good knowledge of forms design, data flow, and the impact of design on the system
Understanding of Quintiles EDC processes and requirements for reporting and study management

Responsibilities

Serve as the EDC System Designer for the build team
Produce accurate and complete specifications documents
Develop eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting
Advise and provide justification for design decisions to Principal Programmer and at Design Meeting
Ensure optimal design reducing the number of edit checks required, good system performance, and utilization of global/client specific libraries for consistency and efficiency
(3-6 months after starting) Provide a draft Edit Check Specification to the DTL
Work closely with the Study DTL and Principal Programmer
Resolve questions and issues with the Principal Programmer, DTL and VTL

Skills

EDC

eCRF Design

Edit Checks

CDM

SAE Reconciliation

External Data Reconciliation

Forms Design

Data Flow

Medical Terminology

Pharmacology

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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