MEDICAL DATA GENERATION MANAGER

Excelya>Full-time>MEDICAL DATA GENERATION MANAGER

Job description

Founded in 2014, Excelya is a ‘people-centred’ contract research organisation (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop service provider model – which is supported by a fully-fledged functional and consultancy service provider – enables our Excelyates to work across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

MISSIONS:

Within the Medical Affairs department, in collaboration with the Product Scientists, Market Access Managers and Health Economics Analysts of his/her therapeutic area, the Medical Data Generation Manager:

  • Oversees and directs the Real World Evidence (RWE), local clinical trials and Investigator Initiated Studies (IIS) programme for a specific product or product group.
  • Provide technical, scientific and operational expertise in the development and implementation of the Integrated Evidence Generation Plan (IEGP).
  • Oversees the project from start to finish, including planning, adherence to procedures, budget, resources and deliverables.
  • Leads and coordinates interactions with internal and external partners to ensure that studies are compliant with regulatory requirements, follow quality standards and that results are published according to the defined plan and timelines.
  • Manages the program budget, updates and reports according to the cycles defined by finance.
  • Acts as the main point of contact for the MAO department in charge of the execution of local prospective studies requiring the collection of adverse events.
  • Leads the activities carried out in the context of project-specific problem and emergency management.
  • Acts as the main contact for project communication and progress.

Profile :

Qualifications/Education:

Doctor of Pharmacy / Postgraduate

Experience and skills: 1 to 3 years minimum, in a similar position.

 

Required:

  • Mastery of pharmaceutical regulations.
  • English: Fluency in English.
  • Significant experience in regulatory affairs (registration and advertising control).

Desirable:

  • Ability to analyse and summarise.
  • Ability to negotiate (understand the needs, propose and argue solutions adapted to one’s strategy and to the regulations).
  • Be organised, rigorous, have a sense of priorities, be dynamic, proactive and be able to manage several contacts and various urgent requests at the same time.
  • Ability to take initiatives and make proposals.
  • Ability to manage complexity, change and uncertainty.
  • Have a sense of responsibility, autonomy and initiative.
  • Ability to work in multidisciplinary and international teams.
  • Be dynamic and able to adapt to different situations.
  • Strong ability to work transversally in an international environment.

Summary

Contact

Apply for this job

Similar career opportunities