Lead Project Manager

ESA - European Society of Anaesthesiology

Lead Project Manager

ESA - European Society of Anaesthesiology

Brussels, Belgium

The European Society of Anaesthesiology (ESA) is the leading European association for Anaesthesia, Critical Care, Pain and Perioperative Medicine. It is a not-for-profit company which promotes the exchange of qualitative information between European anaesthesiologists, in order to improve safety and quality of patient care. The complexity of the business and the number of stakeholders makes this organization quite unique. It therefore requires direction from someone with specific leadership skills, who understands the necessity of ensuring organisational stability while also allowing for continuing growth on the same path.

In order to support their Research Department, ESA is currently looking for a Lead Project Manager to reinforce their CRO division (m/f).

Responsibilities

1. Managing and conducting the coordination and administration of European multi-country clinical studies:

  • Developing, reviewing and managing appropriate study documentation in the Trial Master File (TMF);
  • Periodically reviewing study files for accuracy and completeness and developing study related documents (FAQ, guidance, forms, etc.);
  • Managing study related invoices and tracking study-specific payments;
  • Setting up and maintaining tracking systems and tools;
  • Overseeing the monitoring activities on site and as well as the CRAs/monitors;
  • Attending and organising the study team teleconferences/face to face meetings and writing the meeting minutes.

2. Helping the Chief Investigator and Scientific Team of Studies selected by the ESA Clinical Trial Network/Sponsor in the development of their protocol and study documents:

  • Reviewing protocol and patient consent forms: design, protocol writing, editing.

3. Supporting the participating institutions making constant liaison with the centres, investigators and Sponsor spread over Europe for all activities related to implementation of the Clinical trial locally:

  • Site selection and reviewing side audit reports and identifying the national coordinating investigator;
  • Collecting, reviewing and approving regulatory and ethical documents & registering approval in the appropriate document tracker and saving documents in the electronic and paper file;
  • Investigator fee budget reports distribution to the sites;
  • Monitoring metrics and KPIs for clinical site management activities.

4. Selecting and/or overseeing the Clinical Research Associates (CRAs) spread over Europe for all activities related to monitoring of the Clinical trial locally:

  • Selecting and training CRAs;
  • Monitoring Guidelines and Coordination;
  • Site initiation and co monitoring visits;
  • Collecting data and coordinating and monitoring of data cleaning;
  • Reviewing the budget and tracking invoices.

5. Acting as a central contact for the clinical team for project communications and rolling out of all steps related to the clinical projects.

6. Collaborating with the Data Manager and study statistician assigned to the project.

7. Reporting to the Research Manager and escalating issues to Research Manager and study sponsor.

8. Leading the specific project team and the day to day activities of the assigned project:

  • Leading the CRA selection and inviting the responsible PM to participate to the CRA interview/assessment so they can provide their input as well;
  • Evaluating the CRA in close collaboration with the responsible country PM;
  • Collaborating closely with Research Manager to ensure appropriate level of project oversight deployed;
  • Supervising staff involved in local site contracting and budget management, insurance and payment process;
  • Working with vendor(s) to ensure timely and appropriate planning, resource and capacity management.

Profile

  • You have a higher degree in life sciences or equivalent through experience, and a profound knowledge of good clinical practices and standard operating procedures;
  • You have at least 5 years of relevant experience in project management, preferably within the Pharmaceutical Clinical Trial sector;
  • At least 2 years’ experience of monitoring sites is required. Experience of overseeing CRAs, including reviewing monitoring visit reports, training CRAs and co-monitoring is a plus;
  • You have excellent organizational and planning skills and are able to work effectively in a team/matrix environment on multiple projects;
  • You are a team player with the ability to work independently and autonomously;
  • You are fluent in English. Knowledge of French and Dutch is highly recommended. Any other European language is an asset;
  • Profound knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook) and internet use;
  • Other skills: leadership, problem solving, decision making, relationship management & influencing skills.

Offer

  • Full time position;
  • Office environment and travel approximately 30%.

Questions?

Contact Hanna Lammens on +32 (0)9 242 54 75 or Hanna.Lammens@hudsonsolutions.com.

Don't forget to mention EuroPharmaJobs when applying.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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