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Location

Essonne (91) | France

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Job description

Ividata Life Sciences est la filiale du groupe Ividata qui accompagne les industriels de la santé depuis 2013 sur l'ensemble du territoire français autour de problématiques scientifiques, techniques et opérationnelle. Nos collaborateurs et nos experts interviennent sur les métiers des opérations cliniques, la biométrie & data science, la pharmacovigilance, les affaires réglementaires, l'assurance qualité. Notre ambition ? Challenger l'existant, anticiper demain, et accélérer notre développement tout en étant soucieux de maintenir notre niveau de relation de confiance avec nos consultants et nos clients

Nos consultants sont le coeur de notre réussite : nous sommes convaincus que le bien-être de nos équipes est la clé pour garantir le meilleur accompagnement possible auprès de nos clients.

Fort de ses 300 experts, Ividata propose une approche complète intégrant stratégie, conseil, services et technologie. Ses 3 piliers : excellence, innovation & bien-être.
Missions

At the international level, coordinates, oversees and reports on the local Clinical Operations (monitoring and local study management) to ensure that study-related activities are conducted according to expected quality, timelines and budget. Executes in-house study operations tasks and oversight as delegated by Study Team Leader (STL).

Activities and responsibilities
- Acts as a liaison between field activities in the different countries participating in clinical trials, consolidating, analyzing and disseminating any relevant information to international study personnel and the Study Team
- At the international level, coordinates, oversees and reports on the local/regional Clinical Operations Project Managers (COPMs) to ensure that study-related activities are conducted according to expected quality, timelines and budget
- Actively participates in the study budget creation, train local teams on the budget drivers, estimations and assumptions. In collaboration with the COPMs, develops, manages and reports on the local study budget (external and internal costs)
- Actively participates in Study Team meetings, providing up-to-date and concise information on study progress from the clinical operations perspective, identifying important field operations issues that require input from the Team, proposing solutions and providing also updates on central vendors activities as relevant
- Ensures that the international Clinical Operations personnel are adequately trained on the study and in a timely manner. Provides training in operational aspects to personnel as required. Organizes and participates actively to the Investigator meetings and any other study-related meetings as needed
- Leads the execution of the country and center feasibility and analyses and consolidates the results/feedback to the Study Team. As result of this process, he/she proposes different scenarios to the study team
- In collaboration with the Study Team Leader, identifies an appropriate monitoring strategy, then develops the Monitoring Plan with input from the local COPMs, both for in-house and outsourced monitoring choices
- In collaboration with Study team leader and study team actors, she /he defines the patient in strategies for the clinical trial
- Responsible of the creation/ review and update of key study documentation
- Oversees subject recruitment and retention during the study and, when necessary, pro-actively works with COPMs to develop and propose action plans to the Study Team
- Detects study quality issues trends, root cause analysis & follow-up corrective and preventive actions as necessary (protocol deviations, CAPA plans escalated by local teams, participation in Data Review and Surveillance meetings) and when relevant, reports important issues to the Study Team
- Contributes to the selection, management and oversight as applicable of Full service CROs / central vendors (central lab, central reading, Patient services)
- BE responsible for the oversight of the preparation and deployment of materials, tools and logistics for the study
- During the course of the study, ensures that all necessary study documentation is gathered and correctly filed on a timely basis in the study Trial Master File
- Participates in process definition and optimisation and SOP development efforts with regard to Clinical Operations processes
- Organizes and participates actively to the Investigator meetings and any other study-related meetings as needed, being also responsible for the agenda and the minutes
- Handles any tasks as delegated by the STL - Pharmacist, engineer, degree in science or equivalent
- At least 5 years of experience in clinical operations field
- Proven successful project management & leadership skills
- Very strong organizational and planning management skills (including management at distance)
- Strong interpersonal and communication skills, including the ability to develop and maintain strong
relationships within the Study Team and international study personnel
- Proven experience managing and overseeing third-party vendors (CROs)
- Strong capability to proactively identify risks and apply problem-solving skills
- Ability to work well under pressure, manage multiple tasks in a dynamic environment with shifting priorities
- Excellent knowledge of English (writing and speaking)
- Willingness and ability to travel

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