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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical study management, including site support, patient recruitment, and adherence to regulatory requirements such as ICH GCP and Ergomed SOPs. Proficient in preparing site management documentation and maintaining effective communication with site staff and investigators.
Highest-signal resume keywords
Clinical Research ProcessesSite Management ActivitiesPatient Recruitment StrategiesRegulatory Compliance (ICH GCP, Ergomed SOPs)Fluency 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 SupportPatient RecruitmentInventory OversightReport PreparationETMF FilingStudy Protocol AdherenceTraining and SupervisionLogistical CoordinationRegulatory Requirements Knowledge
Soft Skills
Good Communication SkillsGood Organisational Skills
Industry Keywords
Clinical TrialsInvestigational Medicinal ProductSite CoordinatorsResearch NursesStudy Site Management
About the role
Key responsibilities & impact- Facilitate the conduct of clinical studies, with a focus on patient-related site support
- Maximise utilisation of site staff through site training and oversight of logistically or technically demanding study procedures
- Conduct patient-related site support according to study-specific site management plans
- Ensure clinical studies progress and are conducted, recorded, and reported according to protocols, Ergomed SOPs, ICH GCP, and applicable 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 and facilitate sample shipments
- Notify LSM, CRA, CTM, or PM of site issues
- Establish and 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 on-site or remote visits
- Ensure visit reports, phone contact reports, and correspondence are filed in the eTMF
- Support management of patient travel and other expenses, 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 in conducting site management/site support activities
- Fluent in English and German
- Good communication skills
- Good organisational skills
- Knowledge of clinical research processes, protocols, Ergomed SOPs, ICH GCP, and applicable regulatory requirements
- Ability to support clinical study sites, site staff, investigators, and sub-investigators
- Ability to oversee investigational medicinal product and clinical trial supplies inventory
- Ability to prepare site management visit reports, phone contact reports, correspondence, and eTMF filing
- Ability to support patient recruitment, retention, travel expenses, and site invoicing activities
Benefits
Comp & perks- Remote work available
- Work-life balance
- Career growth opportunities
- Collaborative international team environment
- Opportunity to make an impact in clinical research
- Supportive workplace culture
- Diverse and inclusive workplace
- Employee referral opportunity