Clinical Associate – Regulatory
IQVIA
full-time
Posted on:
Location Type: Remote
Location: Germany
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Tech Stack
About the role
- Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations
- Work and lead complex projects under general supervision
- Serve as Single Point of Contact in assigned studies for investigative sites
- Ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines
- Prepare submission documents and submit to regulatory bodies
- Perform feasibility, site ID, start up and site activation activities according to applicable regulations
- Prepare site documents and review for completeness and accuracy
- Act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role
Requirements
- B Sc degree in Health Sciences or related field
- 1 - 3 years' relevant clinical research experience, specifically in submissions
- Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills in local language
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research experiencesubmissionsEUCTR submission proceduresCTIS submission proceduresfeasibilityCountry Inform Consent adaptationSite Contract negotiationsGCPICHregulatory guidelines
Soft skills
negotiating skillscommunication skillsorganizational skillsinterpersonal skillsability to work independentlyability to prioritize tasksability to manage multiple projects