Study Start-Up Specialist

This is a fully remote position, open to applicants in Germany.

📋 Description

• Accountable for initiating activities in Germany and Austria while providing local expertise.

• Identify deficiencies and potential areas for enhancement, suggesting Corrective and Preventive Actions (CAPA).

• Work alongside the Regional Clinical Study Manager/Start-up Lead to ensure adherence to study timelines and quality standards.

• Offer country-specific expertise in study start-up and assist with budget and contract negotiations.

• Adhere to AMG or GCP-V requirements in accordance with German and Austrian legislation.

• Gather essential documents and conduct reconciliation of essential document site files.

• Carry out an independent quality review of submission packages and either submit them to the Ethics Committee/Health Authority or assist with CTIS submission.

• Review and translate drug labels, informed consent forms, site-specific recruitment materials, and other relevant documents.

• Oversee sites and their performance by monitoring regulatory submissions and key milestones.

• Ensure that start-up study and site documentation are inspection-ready.

• Collaborate with clinical study sites to achieve start-up milestones punctually.

• Assess site practices and escalate any quality or GCP concerns.

• Anticipate and recognize site challenges, proposing corrective and preventative measures.

• Initiate, assist, or lead initiatives aimed at process improvement.

• Foster a culture of operational excellence, innovation, and ongoing improvement.

⛳️ Requirements

• Bachelor’s degree or equivalent in a relevant scientific field.

• Preferred experience in global oncology trials.

• Comprehensive understanding of clinical trial processes, ICH guidelines, and related regulatory frameworks.

• 2-5 years of start-up experience within the pharmaceutical or CRO industry.

• Exceptional communication and interpersonal abilities.

• Strong organizational skills with the capacity to prioritize and manage multiple tasks.

• Proficient in German.

• Competent in both written and spoken English.

• Skilled in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness to travel up to 15%.

🏝️ Benefits

• Equal opportunity employment.

• Travel up to 15%.