German-Speaking Site Manager – Start-Up Experience

About the role

IQVIA is looking for a German-speaking Site Manager with start-up experience to support remote site monitoring of clinical studies. With applicable guidance, you ensure sites carry out their studies and report data as required by the protocol, regulations, guidelines and sponsor requirements, and may monitor or co-monitor on site when needed. You may also perform site identification and site start-up activities.

Key responsibilities

• Complete therapeutic, protocol and clinical research training and work with Clinical Operations Lead, Project Management, Regulatory Start-Up and Epidemiology.
• Perform site identification and site selection, including collecting Site Information Forms and confidentiality agreements, and site selection visits.
• Carry out site start-up: prepare regulatory and ethics submission packages, collect and file regulatory documents, negotiate site contracts and budgets, and agree on project plans and timelines.
• Run initiation, monitoring and close-out visits remotely, and co-monitor on site when needed, following GCP and SOPs.
• Act as primary contact with investigator sites, serve as backup to other Site Managers, and support field CRAs with site training, patient recruitment and retention, study supplies and site issues.
• Review electronic Case Report Form data, resolve data queries, and help with data review, query resolution and casebook signatures before database lock.
• Maintain internal systems and databases, submit visit reports, generate follow-up letters and escalate site performance issues to the Clinical Operations Lead, Clinical Project Manager or Line Manager.
• May attend investigator meetings, request on-site visits or audits, and help ensure timely site payments.

Required profile

• Bachelor's degree preferred, or as required by local country policy; a degree in a scientific discipline or health care is preferred.
• At least 1 year of relevant clinical experience in start-up activities; equivalent education, training and experience may be acceptable.
• Pre-intermediate knowledge of the clinical research process, medical terminology, ICH and GCP guidelines, and study designs.
• Written and verbal German and English, good organisational and problem-solving skills, and ability to manage multiple priorities and meet deadlines.

Required skills

• Proficient use of Microsoft Word and Excel.
• Understanding of electronic data capture and basic data processing.