Study Start-Up Specialist

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

📋 Description

• Execute study initiation activities in Germany and Austria while offering local expertise.

• Identify deficiencies and opportunities for enhancements, and suggest corrective and preventative actions (CAPA).

• Collaborate with the Regional Clinical Study Manager/Start-up Lead to achieve project timelines and uphold quality standards.

• Provide country-specific expertise in study initiation and assist in budget and contract negotiations.

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

• Collect essential documents from study sites and perform reconciliation of essential document site files.

• Review submission packages and present them to Ethics Committees and Health Authorities, or assist with CTIS submissions.

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

• Monitor regulatory submissions and milestones to oversee site performance.

• Ensure the study and site start-up documentation is ready for inspection.

• Work alongside study managers, start-up leads, and clinical study sites to achieve milestones punctually.

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

• Proactively identify and address site challenges, recommend corrective actions, and pinpoint gaps.

• Support operational excellence, innovation, and initiatives for process improvement.

⛳️ Requirements

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

• Experience in global oncology trials is preferred.

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

• 2 to 5 years of start-up experience in the pharmaceutical or Contract Research Organization (CRO) sector.

• Exceptional communication and interpersonal abilities.

• Strong organizational skills with the capability to prioritize tasks and handle multiple responsibilities.

• Fluency in German is mandatory.

• Proficient in both written and spoken English.

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

• Willingness to travel up to 15% of the time.

🏝️ Benefits

• Flexible remote work arrangements.

• Commitment to equal opportunity employment.