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Clinical Project Lead - Clinical Research - Mont-Saint-Guibert

Company

Our client is an innovative company, located in Mont-Saint-Guibert, which is engaged in creating analytical tools with both research and clinical applications. The company strives to improve patient quality of life by supporting physicians’ and pharmaceutical/biotechnology companies’ efforts in identifying the right therapeutic for each individual patient.

Role

You are looking for a professional challenge that allows you to join a fast-moving and young company in order to work in a Clinical Environment?

You want to bring your competences in project management in order to conduct clinical studies for operational and R&D projects? New technologies and innovation is what drives you and your customer mindset allows you to deal easily with your clients?

Plus One can offer you this great challenge:

Your key responsibilities:

The Project Leader is accountable for the delivery within defined timelines and budget of the project/study he/she is in charge of.

The responsibilities include:

  • Project/clinical study kick-off;
  • Translation of Sponsor requirements, if applicable, into concrete tasks for internal team;
  • Project/clinical study planning (time/budget/resources);
  • Project/clinical study management within the defined scope/budget and timelines;
  • Change management including impact assessment on scope/timelines/budget as applicable and reporting to company management;
  • Leading and coordinating the project/clinical study team ;
  • Proactive risks management;
  • Communication management, internally and externally;
  • Regular project monitoring and reporting to Sponsor/company management;
  • Budget management including confirmation of payment milestones completion to accounting department, as applicable;
  • Maintain Project documentation.

For internal R&D clinical studies, the Project Leader will manage the clinical study from study development and protocol medical writing to Clinical Study Report including :

  • Sites and vendors selection;
  • Submission to both Ethics Committee and/or national authorities;
  • Outsourcing of activities;
  • Monitoring as applicable;
  • Trial Master File management.

The Project Leader will also:

  • Ensure lessons learned are incorporated into proposal of process improvements as applicable;
  • Leads process improvements and develops/reviews Standard Operating Procedures/training programs, as needed;
  • Coaches junior Project Leader or team member as applicable;
  • Develops external awareness in his/her filed.

Profile

Education:

  • Master or PhD in Sciences

Professional skills:

  • 3-5 years’ experience as Clinical Project Management
  • Excellent knowledge and experience in management of deadline, budget and risk.
  • Previous experience at a CRO is a strong asset
  • Project Management certification is a plus (PMP, Prince 2, ...)
  • Excellent command of English

Soft skills:

  • Leadership and Ownership
  • Assertiveness
  • Organizational and management skills
  • Effective Communication
  • Customer mindset
  • Negotiation and problem solving
  • Team spirit

Offer

The opportunity to join a fast-moving company with ambitious challenges combined with an international work environment.

Publication date

14.01.2020

Contact person

Gaëlle Minet

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