Service Controller (Refrigeration) - Midrand

Hewitt Colenbrander Recruitment / Hc Recruit; Gauteng; Remote; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Remote work

Health benefits

Career growth

Home office stipend

Job summary

Hewitt Colenbrander Recruitment / Hc Recruit seeks a Data Acquisition Specialist for External Data (Remote/Homebased) to manage external data streams in clinical studies. You will collaborate with stakeholders to ensure accurate data transfer, ingestion, and structure in line with data protection requirements.

Requires a Bachelor’s degree and at least 3 years of clinical data experience, including SDTM and GCP/ICH. Fully remote work and opportunities for growth are offered.

Qualifications

• Bachelor's degree or equivalent, preferably in Computer Science.
• Minimum of 3 years' experience managing data in support of clinical research.
• Experience with external data (Safety Lab, PK, Biomarkers, ECG).
• Experience working with external data providers within a clinical study setting.
• Experience developing data transfer agreements.
• Experience working on clinical trials.
• Experience in diverse, cross-functional, global teams.
• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication in English.

Responsibilities

• Execute deliverables for standardized external data streams.
• Assess external data collection requirements per protocol and planning of setup activities.
• Liaise with data stakeholders to establish data transfer requirements and structure.
• Create change requests for new test concepts or data structures.
• Develop trial-specific Data Transfer Agreements (tsDTAs).
• Ensure data transfer frequencies meet study requirements.
• Liaise with external data providers to align tsDTA.
• Translate medical concepts into data mapping guidance for Clinical programmers.
• UAT of test data transfers against Data Transfer Agreements.
• Implement data transfer mechanisms for external data streams into CDR.
• Monitor availability and accuracy of external data streams with providers.

Skills

Data management

Cross-functional collaboration

Communication

Regulatory compliance

Education

Bachelor's degree

Tools

SDTM

GCP/ICH guidelines

Job description

Data Acquisition Specialist - External Data (Remote/Homebased)

Bloemfontein, South Africa Durban-Inland, KZN, South Africa Centurion, South Africa Bellville, South Africa Full time R

Deliverables

• Execute deliverables for Standardized External Data Streams.
• Assess external data collection requirements per protocol and planning of external data stream set-up activities and related deliverables to meet study start-up timelines.
• Liaise with key data stakeholders to establish the purpose of data collection and requirements for the transfer, ingestion, and structure of data for each data stream in compliance with applicable data protection laws and regulations, utilizing available standards and templates
• Create change requests for the definition of new test concepts or data structures relating to external data.
• Develop trial-specific Data Transfer Agreements (tsDTA's) accurately documenting study requirements and methods for the data transfer, ingestion, and structure.
• Ensure data transfer frequencies are sufficient for the agreed requirements (medical data review, central monitoring, and reporting and analysis).
• Liaise with external data providers to ensure alignment and agreement of tsDTA.
• Translate medical and scientific concepts into data mapping guidance, per agreed data model and documented in the annotated Data Transfer Agreement for use by Clinical programmers.
• UAT of test data transfers ensure accuracy and consistency with data specifications defined in Data Transfer Agreements.
• Implement data transfer mechanisms for external data streams (into CDR) including access for external data providers.
• Monitor availability and accuracy of external data streams, liaise with external data providers to resolve data transfer issues relating to conformance of data.

Education and Experience Requirements

• Bachelor's degree or equivalent, preferably in Computer Science.
• Minimum of 3 years' experience managing data in support of clinical research.
• Experience working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, etc
• Experience in working with external data providers within a clinical study setting.
• Experience developing data transfer agreements.
• Experience working on clinical trials.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines
• Excellent written and verbal communication in English.

Benefits

• Competitive salary and performance-based incentives.
• Fully remote work arrangement, offering unparalleled flexibility.
• Comprehensive health and wellness benefits.
• Opportunities for continuous learning and career growth within a supportive virtual team.
• Allowance for home office setup and internet costs.

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