2023-08-23 14:48:55

Senior CRA/ Clinical Project Manager

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Job Description

We are looking for an experienced Senior CRA / Clinical Project Manager to join our team in Baltics  

Your responsibilities will include management of  medical device investigations, non-interventional studies and clinical phase I–IV studies for medicinal products.

The key responsibilities of the SrCRA /Clinical Project Manager will be: 

  • oversee and drive all aspects of the assigned local and international clinical studies
  • responsible for planning timelines, managing quality, budget, and scope of work
  • provide input on study-related documents (e.g., ICF, eCRF, eTMF, monitor plan, project plan, risk management plans,  set-up and maintenance of study files.
  • ensure projects are managed according to Good Clinical Practice (GCP), local regulations, guidelines, and SOPs in the required standard of quality
  • communicate and share the progress of the project with Medfiles' leadership team, Sponsor, and project team. 
  • manage and lead the cross-functional clinical team and vendors in collaboration with the functional team leads
  • develop contract negotiations with customers and vendor management
  • ensuring project training for all team members is appropriately performed and documented
  • experience with medical device or real world data  is considered an advantage

Requirements

Success in this task requires:

  • experience on international multi-center studies and medical device investigations and/or non-interventional studies 
  • a bachelor’s or a master’s degree in a health-related field
  • experience of working with multidisciplinary groups (internal & external), flexibility, adaptability, and ability skills to work within a matrix environment
  • good understanding of the  product development process and knowledge of the life sciences industry environment
  • good leadership skills and capability to work within a team as leader and team player
  • excellent problem-solving, organizational skills
  • ability to work within stipulated time frames or deadlines even in the face of multiple responsibilities or projects
  • fluent verbal and written English
  • willingness to travel

Company offers

We offer a broad and diverse lead CRA/project manager role in our international, flexible, and inspiring work community. In your work, you will be able to increase your expertise and utilize your knowledge in a very versatile way.  In addition to flexible working practices, such as the possibility to work from home, we support the well-being of our employees with a variety of employee benefits.

Applications with CVs and salary requests are requested to be sent by 12 Aug 2022. For more information on the position, please contact Director Essi Sarkkinen, tel. +358 44 7001 201 (27 July 15:00-17:00 or  2nd August 14:00-16:00 or by email essi.sarkkinen(at)medfiles.eu.

Office location: Estonia (Latvia/Lithuania also an option) 

https://medfiles.rekrytointi.com/paikat/?o=A_A&jid=43