Data Team Lead - homebased (FSP)

IQVIA; Bellville; On-site; ZAR 200 000 - 300 000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Data Manager to oversee data management for clinical trials. This role involves collaborating with trial customers and partners to set expectations, create and track deliverables, and ensure compliance with regulatory guidelines. The ideal candidate will have a strong background in data management, vendor management, and a passion for quality control. Join this dynamic team and contribute to impactful clinical research that drives healthcare innovation. If you are ready to take your career to the next level in a supportive environment, this opportunity is perfect for you.

Qualifications

• 4+ years of data management experience with a focus on clinical trials.
• Experience leading teams and managing vendor relationships.

Responsibilities

• Provide oversight and accountability for clinical trial data management.
• Ensure timely delivery of data management milestones and compliance.

Skills

Data Management

Vendor Management

Quality Control

Clinical Data Oversight

Communication Skills

Education

BS/BA in Health Sciences

Professional Clinical Experience

Tools

RAVE

Job description

• Provides data management support, oversight and/or accountability for one or more clinical trials.
• Take the lead with the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations.
• Creating, planning, and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• With the trial customer and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools.
• Establishes conventions and quality expectations for clinical data.
• Establishes expectations for dataset content and structure.
• Set timelines and follow-up to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML direction.
• Creates clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and audits, as necessary.
• Helps plan, create and track content, format, quality, and timing of data management deliverables, including, but not limited to, Case Report Form, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• Ensures deliverables are on time.
• Participates in the assigned clinical working group(s) to ensure that Data Management and Therapeutic Area trial needs and deliverables are met.
• Helps identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
• Presents and trains at investigator and monitor meetings.

Education/Experience

• BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
• 4 years Data management experience.
• 3 years lead/co-lead experience.
• Vendor Management experience.
• RAVE experience.

This role is not eligible for UK visa sponsorship.