Clinical Data Manager - homebased (FSP)

IQVIA; Bloemfontein; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading clinical research firm is seeking a data management expert with extensive experience in scientific clinical data review. The role requires collaboration with study physicians and managing complex data for oncology-related studies. Candidates should have at least 4 years of relevant experience, Rave knowledge, and the ability to lead data management activities effectively.

Qualifications

• 4+ years of Data Management experience, preferably with clinical data review.
• Knowledge of medical terminology is preferable.
• Must have experience in supporting the eCRF build.

Responsibilities

• Provide scientific data review support for trials.
• Collaborate on establishing data review expectations.
• Review data flows and perform continuous data review activities.
• Participate in study activities from protocol design onwards.
• Manage CDM and SRS/SRP related queries in the EDC system.

Skills

Scientific data review

Collaboration with SRP/SRS

Complex data management

Oncology/CV&M experience

Rave knowledge

Education

BS/BA degree in Health Sciences

Job description

Overview

Looking for a data management expert who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team when implementing data management activities for protocols, focusing on more complex indication and therapy-related elements of the study. Extensive prior experience (4+ years) supporting studies within Oncology or CV&M. Rave experience mandatory.

Responsibilities

• Provide scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
• Collaborate with SRP/SRS, Data Management, and the study team to establish, align, and confirm scientific clinical data review expectations for assigned trials.
• Review all necessary data flows, Data Management Plans, and perform continuous (complex) data review activities on the studies in the assigned program.
• Participate in study activities from protocol design onwards, providing input into study-specific and/or indication-specific data collection tools.
• Review (complex) scientific study data, manage CDM and SRS/SRP related queries in the EDC system. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible.
• Lead and/or attend meetings as appropriate.
• Take a leadership role with SRP/SRS and collaborate with the GDM to establish, align and confirm scientific clinical data review expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners in relation to CDM activities: review content and integration requirements for eCRF and other data collection tools; establish conventions and quality expectations for clinical data; set timelines and follow up regularly to ensure delivery of all Clinical Data Management milestones.
• Create the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Review related clinical data management documents and ensure regulatory compliance and documentation requirements.
• Ensure real-time inspection readiness of all assigned deliverables; participate in Regulatory Agency inspections and client internal audits as necessary.
• Plan and track applicable CDM deliverables to ensure on-time delivery.
• Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
• Identify and participate in process, system, and tool improvement initiatives within clinical data management.
• Therapeutic Area focus: Oncology, Cardiovascular and Immunology.

Education/Experience

• BS/BA degree or higher, preferably in Health Sciences, or equivalent degree with professional clinical experience/exposure.
• 4 years of Data Management experience; experience preferably including clinical data review or significant experience with clinical data review. Knowledge of medical terminology is preferable.
• Must have experience in supporting the eCRF build.
• Rave knowledge and experience mandatory.

This role is not eligible for UK visa sponsorship

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 IQVIA jobs site.