- Experience Level
- Experienced (non-manager)
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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.
As we continue to expand our global operations, we are currently recruiting for a Project Associate to support our Medical Affairs Department in Mannheim, Germany.
In this interesting role you will work under the direction of the Manager of Medical Monitoring Support Centre, assist in performance of administrative tasks related to medical monitoring to ensure that these activities are conducted in accordance with the client and PRA protocol, standard operating procedures (SOPs), International Conference on Harmonization-Good Clinical Practices (ICH-GCP), and all applicable regulatory requirements.
You will be involved in:
- Supporting the team of Medical Monitoring Associates (MMA) and Medical Directors on projects to achieve study objectives and compliance with the protocol.
- Entering and updating data in the appropriate systems according to project specifics described in SMMP/MMP and SOPs.
- Filing and archiving medical documents and relevant communications, documenting all internal and external contacts relating to the protocol in the appropriate systems.
- Managing internal and external medical meetings: Organizing meeting schedules, preparing meeting materials, preparing and disseminating meeting agendas and minutes.
- Maintaining records of the Medical Monitoring Support Center (MMSC) and MD on Duty (in EAPA).
- Operating the FAX server for Medical Affairs.
- Maintaining PD records for projects that have no PRA Medical Monitoring Services contracted.
- Coaching and mentoring team members for specific projects and processes, as needed.
- Completing review of project documentation and subsequent tracking, metrics as necessary.
- Non-project specific responsibilities may include: distribution of mail (post), maintenance of departmental signature sheet, global Team Meeting including Learning Link Codes and MD Training/ presentations
- Assistance for participants of the MD Training Week activities.
- Performing other duties as assigned.
We need a well-organised and approachable Project Associate to provide first class administrative and business support to our international Medical Affairs team.
Administrative experience gained within a CRO or pharmaceutical environment would be desirable although this is not essential and we can consider strong administrators or graduates without this background.
Strong IT skills are essential, in particular MS Word and MS Excel and the ability to take and type up accurate minutes. You will be a strong communicator and have the ability to multi task and work effectively under pressure.
Fluency in English is essential.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.