Senior Clinical Project Manager

Excelya>Full-time>Senior Clinical Project Manager

Job description

Created in 2014, Excelya is a people-centred Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

For our global full-service Clinical Operations department we are looking for a Germany based Senior Project Manager

The Project Manager (PM) is responsible to organize and manage a project to ensure that it complies with approved protocol/amendment(s), ICH-Good Clinical Practice, the applicable SOPs and regulatory requirements, within agreed budget and timelines

PM is the main contact person with the client/sponsor and leads the dedicated Excelya project team.

Responsibilities:

  • Leads and manages the project team’s overall performance, ensuring proper implementation of protocol/amendment
  • Ensures that the project team has all necessary system access and is trained on all specific aspects of the study (e.g. therapeutic area, product, protocol, safety etc) as required by the project management plan
  • Implements and monitors study budget and communicate study milestones to the project team, according to the appropriate financial agreements and documents 
  • Supervises feasibility and site selection during the startup phase of an awarded project 
  • Assists in the preparation and review of all required documents for the study including financial documents 
  • Reviews the submission file and ensures that all required documents and application forms are present and correct. 
  • Identifies all resources required, out of scope activities and requests for change order when applicable
  • Ensures all project deliverables meet customers’ expectations as well as Excelya’s standards.
  • Act as main point of contact to clients where appropriate
  • Reports regularly to the relevant management team the progress of the study, anticipated risks, any delays and the actions taken to correct any deviations.

Skills and experiences demanded:

  • Minimum experience of 8 years in a CRO, Biotech or pharmaceutical company, in the operational and budgetary management of international interventional clinical trials.
  • Minimum 5 years’ experience as Clinical Project Manager, being able to work autonomously
  • Strong interest in the Commercial aspects of a growing CRO
  • Must be fluent in English (written & spoken). Other languages a bonus
  • Organized, dynamic, good communicator, team spirit, leadership.

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