About the Role

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.

Position Overview

Data management expert performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). The role involves tapping into technical and clinical expertise while closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing data management related activities for protocols, with focus on more complex indication and therapy related elements of the study.

Key Responsibilities

• Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial
• 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) as needed
• 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)
• Reviews content and integration requirements for eCRF and other data collection tools
• Establishes conventions and quality expectations for clinical data
• Sets timelines and follows 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
• Participates 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

Deliverables

• Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.

Required Qualifications

• 5+ years Data Management experience performing scientific (complex) clinical data review
• BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure
• Extensive prior experience of 5+ years supporting studies within the therapeutic area Oncology or CV&M
• Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing data management related activities for protocols, with focus on more complex indication and therapy related elements of the study
• 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)
• Rave experience mandatory
• Must have experience in supporting the eCRF build
• Knowledge in medical terminology would be preferable

Therapeutic Area

• Oncology
• Cardiovascular and Immunology

Additional Information

• This role is not eligible for UK visa sponsorship

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.