Clinical Data Manager - homebased (FSP)

IQVIA LLC; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Data Manager to lead data review processes in a home-based role. This position involves collaborating with Study Responsible Physicians and Scientists to ensure high-quality clinical data management. With a focus on Oncology and Cardiovascular studies, the successful candidate will leverage their expertise in Rave and eCRF systems to enhance data integrity and compliance. Join a forward-thinking company that is dedicated to improving patient outcomes through innovative medical treatments. If you have a passion for data management and a commitment to excellence, this opportunity is perfect for you.

Qualifications

• 4+ years of data management experience, especially in clinical data review.
• Must have Rave knowledge and experience, supporting eCRF build.

Responsibilities

• Perform complex clinical data review in collaboration with SRP and SRS.
• Manage data flows and ensure compliance with regulatory guidelines.
• Lead discussions and establish data review expectations for trials.

Skills

Clinical Data Review

Collaboration with Study Responsible Physicians

Data Management

Oncology Knowledge

Rave Experience

Education

BS/BA in Health Sciences

Professional Clinical Experience

Tools

eCRF

EDC System

Job description

Clinical Data Manager - homebased (FSP)

Clinical Data Manager - homebased (FSP)

Apply locations: Reading, Berkshire, United Kingdom; Bloemfontein, South Africa; Dublin, Ireland; Centurion, South Africa; London, United Kingdom

Time type: Full time

Posted on: Posted 13 Days Ago

Time left to apply: End Date: July 1, 2025 (30+ days left to apply)

Job requisition id: R1452488

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 members when implementing the data management related activities for protocols, with a focus on more complex indication and therapy-related elements of the study.

Has prior experience of being involved and driving discussions with SRP/SRS and collaborates with the Data Management team to establish, align, and confirm scientific clinical data review expectations for assigned trial(s). Extensive prior experience of 4+ years supporting studies within the therapeutic area Oncology or CV&M.

Rave experience mandatory

Deliverables:

• 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 who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). Tapping into technical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions, and the rest of the study team members when implementing the data management related activities for protocols, with a focus on more complex indication and therapy-related elements of the study. Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
• Involved in study-related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
• Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in EDC system. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible.
• Leads and/or attends meetings as appropriate.
• Takes a leadership role with SRP/SRS and collaborates 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 related activities:

o Reviews content and integration requirements for eCRF and other data collection tools
o Establishes conventions and quality expectations for clinical data.
o Set timelines and follow‐up regularly to ensure delivery of all Clinical Data Management milestones.

• Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Reviews related clinical data management documents. Ensures compliance with regulatory guidelines and documentation requirements.
• Ensures real‐time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspection and Client internal audits as necessary.
• Plans and tracks applicable CDM deliverables. Ensures CDM deliverables are on time.
• Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
• Identifies and communicates lessons learned, best practices, and frequently asked questions at the trial level.
• Identifies and 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 preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
• 4 years Data management experience. Data Management experience preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be 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.