Clinical Operation Lead

Excelya; Île-de-France; Sur place; EUR 45 000 - 80 000; Plein temps

Résumé du poste

Ein innovatives Unternehmen sucht einen Clinical Operation Lead, um die klinischen Studien auf internationaler Ebene zu koordinieren. In dieser Schlüsselrolle sind Sie verantwortlich für die Überwachung der Studienaktivitäten, die Sicherstellung der Qualität und die Einhaltung von Zeitplänen und Budgets. Sie arbeiten eng mit einem dynamischen Team zusammen, um kreative Lösungen zu entwickeln und die Patientenreise zu verbessern. Wenn Sie eine Leidenschaft für klinische Forschung haben und in einem unterstützenden Umfeld wachsen möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 5 Jahre Erfahrung in klinischen Operationen.
• Starke organisatorische und Planungsfähigkeiten.

Responsabilités

• Koordiniert lokale klinische Operationen und berichtet an das internationale Team.
• Überwacht die Rekrutierung und Bindung von Probanden während der Studie.

Connaissances

Projektmanagement

Führungsfähigkeiten

Organisationsfähigkeiten

Kommunikationsfähigkeiten

Risikomanagement

Formation

Pharmazeut oder Ingenieur

Wissenschaftlicher Abschluss

Description du poste

Why Join Us?

At Excelya, wecombine passion for science with enthusiasm for teamwork to redefineexcellence in healthcare.

Here’s what makes usunique—

We are a young, ambitious health companyrepresenting 900 Excelyates, driven to become Europe’s leadingmid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, andconsulting—enables you to evolve through diverse projects. Workingalongside preeminent experts, you will help improve scientific,operational, and human knowledge to enhance the patient’s journey.

Excelling with care meansbenefiting from an environment that values your natural talents,pushes boundaries with audacity, and nurtures your potential, allowingyou to contribute fully to our shared mission.

About the Job

JoinExcelya, where Audacity, Care, and Energy define whowe are and how we work. We believe in creating bold solutions andfostering an inclusive environment where collaboration and individualgrowth go hand in hand.

You will play a criticalpart in driving innovation and making an impact in the clinicalresearch space, while enjoying a stimulating professional environmentthat encourages personal and intellectual growth.

Main Responsibilities

At the international level, coordinates, supervises and reportson local clinical operations (local study monitoring and management)to ensure that study activities are carried out to quality, on timeand on budget. Carries out study operations tasks internally andprovides supervision as delegated by the Study Team Leader (STL).

Activities and responsibilities

• Acts as a link between field activities in the variouscountries involved in clinical trials, consolidating, analyzing anddisseminating all relevant information to international studypersonnel and the study team.
• At international level,coordinates, supervises and reports to local/regional ClinicalOperations Project Managers (COPMs) to ensure that study-relatedactivities are carried out to the expected quality, time and budget.
• Actively participates in the creation of the study budget,training local teams on budget parameters, estimates and assumptions.In collaboration with COPMs, develops, manages and reports on thelocal study budget (external and internal costs).
• Activelyparticipates in study team meetings, providing up-to-date and conciseinformation on study progress from a clinical operations perspective,identifying significant issues in the field requiring team input,proposing solutions and also providing updates on central supplieractivities as required.
• Ensures that international clinicaloperations staff are properly and timely trained on the study.Provides training on operational aspects to staff as required.Organizes and actively participates in investigator meetings and anyother study-related meetings as required.
• Leads the executionof feasibility by country and center and analyzes and consolidatesresults/feedback to the study team. Following this process, proposesdifferent scenarios to the study team.
• In collaboration withthe Study Team Leader, identifies an appropriate monitoring strategy,then develops the Monitoring Plan with input from local COPMs, forboth in-house and outsourced monitoring options.
• Incollaboration with the Study Team Leader and study team members,defines patient recruitment strategies for the clinical trial.
• Responsible for creating/reviewing and updating key studydocumentation.
• Oversees subject recruitment and retentionduring the study and, if necessary, works proactively with COPMs todevelop and propose action plans to the study team.
• Identifies trends in study quality issues, analyzes rootcauses and monitors corrective and preventive actions where necessary(protocol deviations, CAPA plans escalated by local teams,participation in data review and monitoring meetings) and, whereappropriate, reports significant issues to the study team.
• Contributes to the selection, management and supervision ofCROs/central services (central laboratory, central reading, patientservices) as required.
• Is responsible for supervising thepreparation and deployment of materials, tools and logistics for thestudy.
• During the course of the study, ensures that alldocumentation required for the study is assembled and properlyarchived in a timely manner in the study trial file.
• Participates in the definition and optimization of processesand the development of SOPs for clinical operations processes.
• Organizes and actively participates in investigator meetingsand any other study-related meetings as required, also beingresponsible for the agenda and minutes.
• Manages all tasksdelegated by the STL.

III. Profile

• Pharmacist, engineer, sciencegraduate, or equivalent.
• At least 5 years of experience inclinical operations.
• Proven project management and leadershipskills.
• Very strong organizational and planning managementskills (including remote management).
• Strong interpersonaland communication skills, including the ability to develop andmaintain strong relationships within the study team and internationalstudy staff.
• Proven experience in managing and supervisingexternal contractors (CROs).
• Strong ability to proactivelyidentify risks and apply problem-solving skills.
• Ability towork under pressure and manage multiple tasks in a fast-pacedenvironment with changing priorities.
• Excellent knowledge ofEnglish (written and oral).

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