Job Description

Summary

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As a Clinical Study Manager (CSM), you'll play a pivotal role in advancing the clinical development of innovative imaging agents, ensuring compliance with ICH-GCP and internal standards. This position offers the opportunity to lead small, single-country clinical studies, providing strategic direction and hands-on management throughout the study lifecycle. Working closely with a Clinical Study Director when needed, you'll help shape and execute clinical programs that align with our global development plans--making a real impact in the field of medical imaging and patient care.

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Responsibilities

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Ensure that study activities and milestones are planned, agreed and achieved according to the overall clinical development plan (CDP, if applicable), and the corresponding milestone and recruitment plans Determine the feasibility for running a clinical study in collaboration with other functions as required. Responsible for the timely and accurate preparation of study documentation such as protocols, amendments, case report forms (CRF)/e-CRFs, study plans and study reports in collaboration with other functions and CROs as required. Ensure that the appropriate Regulatory and Ethics Committee submissions and approvals are obtained. Ensure that (Serious) Adverse Event ((S)AE) reporting is performed in compliance with internal and external (S)AE reporting requirements. Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO. Participate in the selection of Services Providers /CROs and other external vendors in collaboration with sourcing department / Strategic Alliances Director and study team. Select (in collaboration with other functions), supervise and actively manage contractors, consultants and external vendors being part of the clinical study, e.g. Central Lab, EDC vendor, Clinical Research Organization (CRO), ECG vendor, etc. as needed.

+ Build strong relationships to maximize performance and value delivered by Service providers
+ Create a culture of joint accountability to ensure Vendor performance
+ Facilitate efficient and collaborative resolution of problems and conflicts with Service Providers
Facilitate vendor training on applicable GEHC SOPs Perform initial contact and participate in the assessment and selection of qualified investigators for inclusion in clinical programs. Oversee performance of Pre-Selection, Initiation, Monitoring, and Closeout site visits. Oversee negotiation and tracking of site budget according to financial agreement with each site Oversee the tracking of subject enrollment at each trial site and provides management with reports of clinical activities, as requested Ensure that clinical trial sites have adequate supplies to perform the trial Manage Clinical Study budget Attend monthly Clinical Research Meeting to report on progress of their assigned study/ies Participate in the development and review process of globalization and harmonization such as Standard Operating Procedures, guidelines, and forms. Identify and communicate areas for improvement within local and global Clinical Research infrastructure at GEHC In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks. Make sure daily operation of clinical study is in line with QA system and regulation and ensures the project team maintains a continuous state of audit readiness. In collaboration with the Medical Director, identify study committee members (such as steering committee, publication committee), ensure contracts and charters in place and ongoing oversight and management is performed. Attend Competent Authority/Ethics Committee study review meetings as required.

Qualifications and Requirements

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Degree in a science related field with proven experience of clinical phase 1 - 4 study management within the healthcare industry or equivalent Good prior knowledge of all aspects of the clinical study process including planning, execution and reporting/publication of results Proven communication skills, both written and verbal, at all levels of an organization

Desired Skills

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Excellent written and oral communication skills, interpersonal skills and good presentation skills Well organized and structured, attention to detail Ability to work independently and systematically Diplomatic, cooperative team worker Decisive attitude Proven ability to manage complex studies and/or multiple studies across different regions Proven leadership skills Must be willing to travel as required, for study team meetings, site visits, client presentations and other professional meetings/conferences as needed. Have a flexible approach

Inclusion and Diversity

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GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

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We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Total Rewards

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Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.


#LI-BG1

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Responsabilites

Veiller a ce que les activites et les jalons de l'etude soient planifies, valides et atteints conformement au plan global de developpement clinique (CDP, le cas echeant), ainsi qu'aux plans de jalons et de recrutement correspondants. Determiner la faisabilite de la mise en oeuvre d'une etude clinique en collaboration avec les autres fonctions concernees. Etre responsable de la preparation en temps voulu et avec precision de la documentation de l'etude (protocoles, amendements, formulaires de rapport de cas (CRF)/e-CRF, plans d'etude et rapports d'etude), en collaboration avec d'autres fonctions et CRO si necessaire. S'assurer que les soumissions et les approbations reglementaires et ethiques appropriees sont obtenues. Garantir que la declaration des evenements indesirables (graves) ((S)AE) est effectuee conformement aux exigences internes et externes. Apporter une expertise pour la redaction des specifications d'externalisation clinique et faciliter la selection des prestataires de services/CRO via les documents RFP. Participer a la selection des prestataires de services/CRO et autres fournisseurs externes en collaboration avec le departement des achats / Directeur des Alliances Strategiques et l'equipe d'etude. Selectionner (en collaboration avec d'autres fonctions), superviser et gerer activement les sous-traitants, consultants et fournisseurs externes impliques dans l'etude clinique (ex. : laboratoire central, fournisseur EDC, CRO, fournisseur ECG, etc.). Etablir des relations solides pour maximiser la performance et la valeur ajoutee des prestataires. Creer une culture de responsabilite partagee pour garantir la performance des fournisseurs. Faciliter la resolution efficace et collaborative des problemes et conflits avec les prestataires. Organiser la formation des fournisseurs sur les SOPs applicables de GEHC. Effectuer le premier contact et participer a l'evaluation et a la selection des investigateurs qualifies pour inclusion dans les programmes cliniques. Superviser les visites de preselection, d'initiation, de suivi et de cloture des sites. Superviser la negociation et le suivi des budgets des sites selon les accords financiers. Suivre le recrutement des sujets sur chaque site et fournir des rapports d'activites cliniques a la direction, sur demande. S'assurer que les sites disposent des fournitures necessaires pour mener l'etude. Gerer le budget de l'etude clinique. Participer aux reunions mensuelles de recherche clinique pour faire le point sur l'avancement des etudes assignees. Participer au developpement et a la revision des procedures de globalisation et d'harmonisation (SOPs, lignes directrices, formulaires). Identifier et communiquer les axes d'amelioration de l'infrastructure de recherche clinique locale et globale chez GEHC. En collaboration avec l'equipe projet, diriger l'identification, l'evaluation et la gestion proactive des risques lies a l'etude clinique. Veiller a ce que les operations quotidiennes de l'etude soient conformes au systeme qualite et a la reglementation, et que l'equipe projet soit en etat de preparation continue a un audit. En collaboration avec le Directeur Medical, identifier les membres des comites d'etude (ex. : comite de pilotage, comite de publication), s'assurer que les contrats et chartes sont en place, et assurer leur supervision continue. Participer aux reunions d'evaluation des etudes par les autorites competentes/comites d'ethique, si necessaire.
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Qualifications et exigences

Diplome dans un domaine scientifique avec une experience averee en gestion d'etudes cliniques de phase 1 a 4 dans l'industrie de la sante ou equivalent. Bonne connaissance prealable de tous les aspects du processus d'etude clinique, y compris la planification, l'execution et la publication des resultats. Competences averees en communication ecrite et orale a tous les niveaux de l'organisation.
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Competences souhaitees

Excellentes competences en communication ecrite et orale, aisance relationnelle et bonnes capacites de presentation. Sens de l'organisation, rigueur et attention aux details. Capacite a travailler de maniere autonome et methodique. Esprit d'equipe, diplomatie et cooperation. Attitude decisive. Capacite demontree a gerer des etudes complexes et/ou multiples dans differentes regions. Competences en leadership averees. Disponibilite pour voyager selon les besoins (reunions d'equipe, visites de sites, presentations clients, conferences professionnelles, etc.). Flexibilite dans l'approche de travail.

Additional Information

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Relocation Assistance Provided:

No