Clinical Data Manager (Data Review)

Findojobs South Africa; South Africa; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A leading clinical research provider is seeking a Clinical Data Manager to perform complex data review and collaboration within clinical trials. The role involves ensuring quality and compliance in data management activities, supporting various therapeutic areas including Oncology and Cardiovascular. Candidates should possess a degree in Health Sciences and significant experience in data management and clinical data review.

Qualifications

• BS/BA degree or higher in Health Sciences or related field.
• At least 5 years of Data Management experience.
• Knowledge of medical terminology.

Responsibilities

• Perform scientific clinical data review and collaboration with SRP/SRS.
• Manage and review data flows and Data Management Plans.
• Ensure inspection readiness and participate in audits.

Skills

Data Management

Clinical Data Review

Collaboration

Regulatory Compliance

Quality Assurance

Education

BS/BA degree in Health Sciences or related field

Job description

The Clinical Data Manager (CDM) will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

• Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
• The data management expert, within the therapeutic area, performs scientific (complex) clinical data review in close collaboration with SRP and SRS, leveraging technical and clinical expertise. Collaborates with SRP, SRS, Data Management, and other study team members to implement data management activities, focusing on complex indication and therapy-related elements. Reviews data flows, Data Management Plans, and performs continuous complex data review activities.
• Involved in study activities from protocol design, providing input into data collection tools.
• Reviews scientific study data, manages CDM and SRS/SRP queries in eDC system, and discusses findings with SRS/SRP. May be involved in coding and SAE reconciliation. Leads or attends meetings as appropriate.
• Leads collaboration with SRP/SRS and GDM to establish and confirm scientific clinical data review expectations for assigned trials.
• With trial stakeholders, reviews eCRF content, establishes data conventions and quality expectations, and sets timelines for CDM milestones.
• Creates the Integrated Review Plan, ensuring quality, scientific content, clarity, accuracy, and regulatory compliance. Reviews related documents.
• Ensures inspection readiness of all deliverables; participates in inspections and audits as necessary.
• Plans, tracks, and ensures timely delivery of CDM activities.
• Collaborates with SRS/SRP to meet trial needs and deliverables.
• Identifies lessons learned, best practices, and FAQs at the trial level.
• Participates in process, system, and tool improvement initiatives within clinical data management.

Therapeutic Area: Oncology, Cardiovascular, and Immunology

Education/Experience:

• BS/BA degree or higher in Health Sciences or related field, or equivalent professional clinical experience.
• At least 5 years of Data Management experience, preferably including clinical data review and knowledge of medical terminology.
• Experience collaborating with clinical teams.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create connections to accelerate the development and commercialization of medical treatments to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com .