Clinical Project Director/ Chef de Projet Clinique

at  GE Healthcare

JOB DESCRIPTION SUMMARY

The role of the CPD is to support the clinical development of new imaging agents in accordance with ICH-GCP and Standard Operating Procedures (SOPs).
The CPD acts as the Study Manager for assigned large, global and/or complex Clinical studies and provides the study team with overall direction, clear expectations for deliverables and the leadership necessary for the successful management, conduct and completion of a clinical study program. To plan, implement and drive all aspects of clinical studies according to the Global Clinical Development Plan (CDP), Product Program Plans and in compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOP), Corporate Policies, Guidelines and internal Standards.

REQUIRED QUALIFICATIONS

• This role requires significant experience in the Engineering/Technology & Clinical Project Management. Knowledge level is comparable to a Master’s degree from an accredited university or college ( or a high school diploma with relevant experience).
• Proven extensive experience of complex clinical phase 1 – 4 study management within the healthcare industry
• Excellent 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

QUALIFICATIONS REQUISES

• Ce rôle nécessite une expérience significative en gestion de projet clinique. Le niveau de connaissance est comparable à un diplôme de Master d’une université ou d’un collège accrédité (ou un diplôme de lycée avec une expérience pertinente).
• Expérience avérée dans la gestion d’études cliniques complexes de phase 1 à 4 au sein de l’industrie de la santé.
• Connaissance approfondie de tous les aspects du processus d’étude clinique, y compris la planification, l’exécution et la publication des résultats.
• Compétences en communication prouvées, tant écrites qu’orales, à tous les niveaux d’une organisation.

• 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
• May supervise the work of less experienced study managers
• 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.