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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in facilitating clinical studies, ensuring compliance with protocols, SOPs, ICH GCP, and regulatory requirements, while effectively managing site staff and supporting patient recruitment strategies.
Highest-signal resume keywords
Clinical Study FacilitationSite Management SupportICH GCP CompliancePatient Recruitment StrategiesFluent in English and German
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site ManagementClinical Study ProtocolsRegulatory RequirementsInventory ManagementETMF FilingSite Visit Report PreparationPatient Travel Expense Management
Soft Skills
Good Communication SkillsGood Organisational Skills
Industry Keywords
Investigational Medicinal ProductClinical Trial SuppliesStudy Site CoordinatorsResearch NursesSub-Investigators
About the role
Key responsibilities & impact- Facilitate the conduct of clinical studies
- Provide patient-related site support according to study-specific site management plans
- Maximise utilisation of site staff through site training and oversight of logistically or technically demanding study procedures
- Ensure clinical studies progress and are conducted, recorded, and reported according to protocols, SOPs, ICH GCP, and regulatory requirements
- Act as primary contact for Study Site Coordinators and Research Nurses
- Participate in Site Manager training
- Provide continuous training, consultation, support, and supervision to Study Site Coordinators
- Assist with patient recruitment and retention strategies and track recruitment activities
- Oversee investigational medicinal product and clinical trial supplies inventory
- Facilitate shipment logistics for samples
- Notify LSM, CRA, CTM, or PM of site issues
- Maintain relationships with site coordinators, research nurses, investigators, and sub-investigators
- Participate in internal team teleconferences and site management meetings
- Prepare Site Management Visit reports after onsite or remote visits
- Ensure visit reports, phone contact reports, and correspondence are filed in the eTMF
- Support patient travel expense management, calculation sheets, and site invoicing
Requirements
What you’ll need- Educated to degree standard, preferably in medical/public health field, or appropriate equivalent work experience
- Previous experience conducting site management/site support activities
- Fluent in English and German
- Good communication skills
- Good organisational skills
- Experience with clinical study protocols, Ergomed SOPs, ICH GCP, and applicable regulatory requirements
- Ability to support study site coordinators, research nurses, investigators, and sub-investigators
- Ability to manage investigational medicinal product and clinical trial supplies inventory
- Ability to prepare site management visit reports and maintain eTMF filing
- Ability to support patient travel expense management and site invoicing
Benefits
Comp & perks- Flexible remote work arrangements
- Work-life balance
- Collaborative, international team environment
- Career growth opportunities
- Trusted ownership and autonomy
- Supportive workplace culture
- Opportunity to contribute to meaningful clinical research that helps bring safe and effective pharmaceutical treatments to patients