Clinical Project Manager 3496

13-9-2019 braine-l'alleud
description de la société

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions


description de la fonction

You have at least three years’ relevant experience in clinical development ? You also have experience in Clinical trial management in Early and Late Phase and in team leadership?

Don't hesitate to contact me: aurelia.sautiere@cx.ausy.be

  • Lead one or more multi-functional, Clinical Study Team(s) 
  • If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit 
  • At the study kick-off meeting, articulate study scope, goals, and expectations of  the company to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning
  • Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings
  • Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit
  • Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate
  • Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget
  • Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO
  • Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) 
  • Understand, manage, track and ensure accuracy of study budgets 
  • For assigned studies, work closely with the respective Program Delivery Leads, and other team members and stakeholders as required
  • Collaborate with members of Clinical Study Team(s) / Joint Clinical Study teams to develop clinical trial protocols, protocol amendments, and other relevant study documents by providing input and/or approval as defined in SOPs 
  • Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate)
  • Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings 
  • Support Data cleaning and data evaluation meetings (DEM) and Results Interpretation Meetings
  • Ensure that Clinical Study Reports meet the objectives of the trial and correctly reflect the data and the study conduct, in collaboration with the study team members
  • Lead lessons learned meetings as appropriate for assigned studies with internal and CRO team members
  • Ensure quality and adherence to the relevant  SOPs, GCP, regulatory guidelines and working practices
  • Support any audit/inspection activities 
  • Provide study specific training for internal and external  team members
  • Travel including overnight stays- possibly global - required

vos atouts

  • At least three years’ relevant experience in clinical development including team leadership
  • Clinical trial management in Early and Late Phase and team leadership
  • Motivation, mentoring and integration of individuals on multi-functional international teams
  • Delivery of scientific/medical presentations and training to both large and small audiences 
  • Excellent verbal and written communication in English
  • Proficiency in the Microsoft office suite 
  • Good interpersonal skills
  • Excellent time management and organizational skills
  • Negotiation skills
  • Scientific and technical knowledge:

- GCP and regulatory environment

- Medical knowledge and research expertise 

- Basic principles of data management and statistics

  • Proactive approach, drive and follow through

qu'offrons-nous?

We offer an attractive salary with extra-legal advantages : 

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car 
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible


sommaire
fonction
chef de projet / manager (m/f)
type de job
temps plein, freelance
type contrat
missions à long terme
référence
CXRSP-84054
informations de contact
Aurélia Sautière
aurelia.sautiere@cx.ausy.be 02 474 60 16
02 474 60 16