Ividata Life Sciences

Consultant

• Review of synopses and protocols
• Supervision of statistical deliverables produced by external providers
• Monitoring the progress of statistical operations
• Ensure delivery of TFLs and results within agreed timelines
• Delivery of analysis datasets

Consultant, RWE Biostatistician

Public Relations

• Draft and review preclinical study synopses
• Coordinate the operational execution and logistics of studies with CROs
• Analyze and interpret bioanalytical data
• Ensure compliance with protocols and timely delivery of study reports
• Assess CRO technical capabilities, negotiate and manage contracts
• Contribute to the collection of PK/PD data and the nonclinical PK strategy
• Review and validate TK/PK documents for regulatory submissions

Consultant, Preclinical Pharmacokinetics

• Review the legal and scientific compliance of promotional materials and projects
• Prepare, submit and track PM Visa application dossiers with the ANSM (French National Agency for Medicines and Health Products Safety)
• Ensure compliance of interactions with healthcare professionals
• Monitor updates to ANSM recommendations and provide training to internal teams

Consultant – Regulatory Affairs, Advertising Compliance

• Lead and coordinate PMCF (Post-Market Clinical Follow-up) data collection
• Design and implement simple post-market clinical studies
• Draft study protocols, case report forms (CRFs), and final clinical study reports
• Ensure collected data comply with the MDR (EU Medical Device Regulation 2017/745) requirements
• Provide methodological support to investigator physicians
• Manage timelines, monitor enrollments, and liaise with hospitals and clinical sites
• Lead regulatory activities and necessary submissions

Consultant – RWE Project Manager, Medical Devices

• Prepare periodic signal detection reports
• Participate in the analysis and assessment of safety signals
• Contribute to the preparation of periodic pharmacovigilance reports
• Participate in Risk Management activities
• Ensure the scientific and regulatory quality of deliverables

Pharmacovigilance Consultant – Signal Detection

• Draft clinical study report lay summaries (CSR lay summaries) and protocol synopses in plain language
• Convert complex scientific and statistical data into accessible, neutral patient-facing content (CSR, protocols, statistical outputs)
• Ensure deliverables comply with European regulatory requirements (EU CTR 536/2014) and the CTIS portal
• Coordinate review cycles and approvals with subject-matter experts (Clinical, Biostatistics, PV, Regulatory)
• Manage document scheduling and maintain strict version control to ensure publication deadlines are met
• Ensure terminological consistency and the scientific quality of documents intended for the institutional website
• Lead assessment of timeline-related risks and propose mitigation plans during periods of high activity

Consultant, Senior Medical Writer

Backend Engineer

• Design and develop Python applications for aggregating and visualizing results from bioinformatics pipelines.
• Perform processing and analysis of sequence data.
• Adapt outputs from existing pipelines to ensure interoperability with visualization tools.
• Provide corrective and evolutionary maintenance for existing bioinformatics applications.
• Write associated technical and functional documentation.

Consultant, Bioinformatics, Data App Developer – Python

• Ensure the setup, monitoring and close-out of investigational sites
• Conduct on-site monitoring (7 to 8 trips per month)
• Verify source data consistency (SDV) and compliance with GCP/ICH
• Manage study logistics
• Identify and resolve on-site issues
• Write visit reports and track corrective actions
• Maintain clear communication between the sponsor and investigational sites

CRA Consultant, Junior Clinical Research Monitor

• Participates in the planning, coordination and production of periodic safety deliverables
• Contributes to the ongoing assessment of products' benefit–risk profiles and to the identification of safety issues
• Supports the preparation, update and monitoring of risk management plans and measures
• Coordinates internal and external contributions required for the production of safety documents
• Ensures compliance with regulatory requirements, deadlines and quality standards
• Takes part in project meetings and cross-functional discussions as the safety point of contact

Consultant – Safety Periodic Reports Lead

• Draft regulatory documents in accordance with internal procedures and EMA and FDA regulatory requirements
• Support teams in clinical submissions for Phase II and Phase III studies
• Prepare Brief Packs and Clinical Briefs for the FDA & EMA
• Draft and/or update Investigator Brochures, INDs & IMPDs
• Prepare PIP waivers and Orphan Drug dossiers
• Ensure cross-functional communication between regulatory, clinical, and medical affairs teams

Consultant – Medical Writer

• Lead statistical support and act as the primary point of contact for all assigned study activities
• Ensure the scientific validity and quality of statistical deliverables
• Write and/or review major technical documents
• Program and/or validate statistical analyses
• Perform advanced analyses
• Contribute to the interpretation of results and the development of key messages
• Ensure regulatory compliance