Clinical Data Manager - homebased (FSP)

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:

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

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.