Clinical Data Manager (Data Review)

IQVIA Argentina; Bellville; On-site; ZAR 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Data Manager to oversee complex clinical data reviews in collaboration with study physicians and scientists. This role involves ensuring adherence to regulatory standards, leading data management activities, and enhancing data quality for clinical trials in therapeutic areas like Oncology and Cardiovascular. The ideal candidate will have a strong background in data management and clinical experience, contributing to the improvement of patient outcomes through effective data handling. Join a forward-thinking team dedicated to advancing healthcare solutions.

Qualifications

• 5+ years of Data Management experience with clinical data review.
• Strong knowledge of medical terminology and data management processes.

Responsibilities

• Perform scientific clinical data review in collaboration with study teams.
• Ensure quality and regulatory compliance of clinical data deliverables.

Skills

Clinical Data Review

Data Management

Medical Terminology

Collaboration with Clinical Teams

Education

BS/BA in Health Sciences

Equivalent Professional Clinical Experience

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).

Deliverables:

1. Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
2. Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
3. 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.
4. Involved in study activities from protocol design, providing input into data collection tools.
5. 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.
6. Leads collaboration with SRP/SRS and GDM to establish and confirm scientific clinical data review expectations for assigned trials.
7. With trial stakeholders, reviews eCRF content, establishes data conventions and quality expectations, and sets timelines for CDM milestones.
8. Creates the Integrated Review Plan, ensuring quality, scientific content, clarity, accuracy, and regulatory compliance. Reviews related documents.
9. Ensures inspection readiness of all deliverables; participates in inspections and audits as necessary.
10. Plans, tracks, and ensures timely delivery of CDM activities.
11. Collaborates with SRS/SRP to meet trial needs and deliverables.
12. Identifies lessons learned, best practices, and FAQs at the trial level.
13. 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.