Freelance Clinical Research Associate

Jobtailor; Deutschland; Remote; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Clinical Study Site Manager to oversee site initiation, monitoring, and close-out for clinical studies in Germany. You will ensure data quality, regulatory compliance, and timely study completion across multiple sites, working with SOPs and ICH-GCP guidelines.

The role requires 2+ years of on-site monitoring experience, the ability to prepare ethics submissions, strong communication skills, and fluency in English and local languages.

Qualifikationen

• University degree in medicine, pharmacy, nursing or life science.
• 2+ years of on-site monitoring experience in CRO or pharma.
• Freelancing experience is a plus.
• Experience in ethics/regulatory submissions.
• Strong written, verbal and presentation skills.
• Fluency in English and local languages.
• Attention to detail and high scientific standards.

Aufgaben

• Manage site management: initiation, monitoring, close-out, and file maintenance.
• Ensure data quality, SOP compliance, regulatory adherence, and timely study completion.
• Conduct site monitoring according to Dokumeds and Sponsor SOPs, and ICH-GCP.
• Perform country and site feasibility assessments.
• Prepare and submit documentation to Ethics Committees and Regulatory Authorities.
• Assist with site contract management.

Kenntnisse

On-site monitoring

Regulatory knowledge

Quality-minded

Documentation skills

Presentation skills

Ausbildung

Medicine

Pharmacy

Nursing

Life science

Jobbeschreibung

• Manage all aspects of study site management, including site selection, initiation, routine monitoring, close-out, and maintenance of study files
• Ensure data quality and integrity, compliance with relevant SOPs and regulatory requirements, and study completion on time and within budget
• Perform site administration and monitoring for assigned clinical studies according to Dokumeds and Sponsor SOPs, legal requirements, and ICH-GCP Guidelines
• Conduct country and site feasibility
• Conduct site initiation, routine monitoring, and close-out visits
• Prepare and submit documentation to Ethics Committees and Regulatory Authorities
• Assist with site contract management

Requirements

• University degree in medicine, pharmacy, nursing or life science
• At least 2 years of previous on-site monitoring experience in CRO or Pharma company
• Previous freelancing experience will be considered as an advantage
• Previous experience in preparation and submissions to Ethics Committees / Regulatory Authorities
• Strong written, verbal and presentation skills
• Fluency in both English and local languages
• Attention to detail and understanding of high-quality scientific standards
• Honesty, integrity, loyalty, accountability, mutual trust, and strong team spirit
• Critical thinking and ability to craft novel, practical solutions
• Ability to change quickly, anticipate and respond to changes, and manage risk
• Driver license and ability to travel
• CV submitted in English

Core Competencies

Demonstrates expertise in clinical study site management, including site selection, monitoring, and compliance with regulatory requirements. Proficient in preparing documentation for Ethics Committees and Regulatory Authorities while ensuring data quality and integrity.

Highest-signal resume keywords

• Clinical Study Site Management
• On-Site Monitoring Experience
• Preparation for Ethics Committees
• Regulatory Compliance
• Fluency in English and Local Languages

Hard Skills

• Site Selection
• Routine Monitoring
• Close-Out Visits
• Data Quality Assurance
• Regulatory Requirements
• ICH-GCP Guidelines
• Site Administration
• Feasibility Studies
• Contract Management
• Documentation Preparation

Soft Skills

• Attention to Detail
• Critical Thinking
• Strong Written Communication
• Strong Verbal Communication
• Presentation Skills

Certifications & Qualifications

• University Degree in Medicine
• University Degree in Pharmacy
• University Degree in Nursing
• University Degree in Life Science

Industry Keywords

• CRO
• Pharma
• SOPs
• Ethics Committees
• Regulatory Authorities
• Scientific Standards