Project Assistant – Clinical Studies
Alcedis - a HUMA company
full-time
Posted on:
Location Type: Hybrid
Location: Gießen • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support in organizing the study at investigational sites and in managing investigators
- Query study status at investigational sites (following a predefined guide) and document findings
- Train investigators and site coordinators on the study and on the EDC software
- Conduct feasibility assessments for new projects with investigational sites
- Support the preparation of study documents, including shipping and tracking
- Prepare documents for submission to regulatory authorities and ethics committees
- Create and maintain the Study Master File (SMF)
- Support sites in addressing queries related to electronically captured study data
- Correspondence (using templates or independently, in German and English)
- Shipping and tracking of documents and study materials to investigational sites
- Drafting/editing study contracts (according to templates/guidance)
- Prepare documentation for site remuneration/payment
- Organize investigator meetings
- Prepare presentations, charts and tables (independently and per instruction)
- Provide support to the project support team
Requirements
- Completed vocational training in a medical or commercial/business field
- Ideally, experience in the organization of clinical trials
- Independent and analytical working style
- Good knowledge of the MS Office suite
- Team player with flexibility
- Excellent communication and organizational skills
- Good command of English (written and spoken)
Benefits
- 30 days of vacation based on a 5-day work week
- Flexible working hours
- Overtime compensation (time off or equivalent)
- Option to work up to three days per week from home (60:40 model)
- Company bike (bike leasing)
- Employer savings contributions (VWL)
- Additional pay for health promotion
- Regular company events and team-building activities
- Learning and development opportunities (e.g., Babbel app)
- Free electric vehicle (EV) charging stations
- Fresh fruit basket and unlimited beverages
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial organizationfeasibility assessmentsstudy document preparationstudy contract draftingstudy data managementregulatory submission preparationstudy master file maintenanceinvestigator trainingdata query managementpresentation preparation
Soft skills
independent workinganalytical skillscommunication skillsorganizational skillsteam playerflexibility
Certifications
vocational training in medical fieldvocational training in commercial/business field