Clinical Trial Manager (m/f/d)

Job Responsibilities

• Lead and oversee the operational execution of clinical trials, ensuring compliance with regulatory requirements and internal quality standards.
• Monitor study timelines and ongoing study activities from start-up to study close-out including data cleaning.
• Collaborate with and oversee the activities of manual Reading Centers in clinical trials, ensuring timely data delivery, regulatory compliance, and efficient communication.
• Work closely with relevant internal teams to ensure seamless data transfers, processing, and interpretation of study data within the study framework.
• Identify and mitigate potential risks in study execution and escalate issues as needed.
• Compile, prepare and maintain project-specific status reports.
• Coordinate project meetings and keep quality meeting minutes.
• Participate in regular meetings with sponsors and external stakeholders.
• Ensure a timely delivery of recurrent tasks with a high degree of accuracy.
• Act as contact for study stakeholders, including site staff, sponsors, and vendors.
• Assist in invoice preparation while maintaining oversight of budgets and related financial documentation.
• Prepare and review clinical trial documents, including study protocols, proposals, contracts, study-specific manuals, data transfer agreements and SOPs.
• Support site training initiatives on the use of AI-based evaluation tools and ensure sites adhere to the correct data submission process.
• Contribute to process improvements and best practices within clinical operations.

Your Profile

• Scientific degree is preferred
• Prior experience in clinical trial management, ophthalmology or with reading centers is a plus
• Language: Fluent English (oral and written), German is a plus
• Good computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• Knowledge of GDPR, ICH/GCP and all other applicable laws, rules, and regulations
• Well-structured and precise working style
• Good planning, time management and prioritization skills
• Proactive and problem-solving mentality
• High degree of independence and responsibility
• Curiosity about clinical trials and artificial intelligence and openness to new projects and challenges
• Team player personality and good communication skills

Our Offer

• Room for your own ideas and possibility to grow in your role
• Friendly and supportive team culture that values diversity
• Free snacks and fruits as well as a fridge with beverages and coffee in the office
• Spontaneous table tennis, darts, drinks, movies after work in the office and periodically occurring team building events
• Flexible working hours for a healthy work-life balance with home office possibilities
• EUR 42.224,00 per year (on full-time basis, 38.5 hours/week based on the collective agreement) with the willingness to overpay according to your qualification and responsibility

Fits your current situation? Apply now directly or by e-mail to career@retinsight.com! This job posting will close once enough applications have been received, so don't hesitate to apply. We look forward to receiving your application - a letter of motivation along with your CV would be a strong plus.

Seniority level

Entry level

Employment type

Full-time

Industries

Software Development