PRA Health Sciences

Clinical Team Manager

Finland, Helsinki
12 Mar 2021
11 Apr 2021
Full Time
Contract Type
Experience Level

We don’t tell our employees what they should care about. They tell us.

At PRA, Philanthropy, charitable giving and social responsibility are more than buzz words for us – they’re ideas we hold up as ideals. Our passion and commitment to improving lives extend far beyond our work and we believe that it is our obligation to empower our employees to find meaningful ways to respond to the needs of others around the world.

We are looking for a Study Lead Monitor, who will be dedicated to one of our global pharmaceutical clients; a client with which PRA shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in this exclusive program.

The Study Lead Monitor (SLM) is a key member of the Core Study Team and is the representative for monitoring, site management and country performance matters. This expertise provides functional leadership and operational oversight of the country teams involved in the study and will improve the overall compliance and quality with a clear focus on training, oversight, prompt issue identification and resolution. Key responsibilities include (but not all):

  • Leadership. Lead and motivate the geographically dispersed CLMs and CRAs assigned to the study and be responsible for overseeing operational aspects of monitoring and site management (from site feasibility to close out).
  • Collaboration and Contribution. Represent monitoring and site management aspects in the Core Study Team. Working in a matrix organization ensure that information flows from Study team to country teams and other collaborators and vice versa.
  • Be responsible and accountable for all study specific training for CLMs and CRAs. Have quality oversight of monitoring and site management activities.
  • Tracking and Reporting. As a key member of the Global Study Team, ensure proper tacking of monitoring and country relevant topics.
  • Preparation of Documents. Responsible for developing the monitoring plan and study specific forms, contribute to the development of recruitment and retention strategies and tools. Contribute to the protocol, study and oversight plan development specially with regard to monitoring and operational aspects.
  • Quality Risk Identification and Handling. Contribute to the audit and inspection readiness of the allocated study.

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • Bachelor’s degree (or more) or equivalent
  • At least 5 years of relevant clinical trial experience including 4 years monitoring and/or 2 years of CLM/Country Project Management experience
  • Expert in monitoring and site management processes and in-depth knowledge of Good Clinical Practices (GCP) and international Regulations.
  • Ability to work with a multi-cultural and geographically diverse team.
  • Comprehensive knowledge of the drug development process including monitoring and site management, regulatory requirements, drug safety requirements, and data management processes
  • Fluency English and Finnish is essential.
  • The right to live and work in Finland. PRA does not sponsor work visas for non-EU nationals.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.