Site Specialist II, German Speaker

This is a fully remote position, open to applicants in Bulgaria, +1 more country.

📋 Description

• Oversee a variety of site-level tasks that facilitate study initiation and/or ongoing maintenance throughout the study lifecycle.

• Coordinate the gathering, evaluation, and upkeep of essential site documentation.

• Assist with site initiation and regulatory processes in compliance with EU CTR and/or CTD standards in Switzerland.

• Serve as a primary operational liaison for DACH investigator sites.

• Offer expertise on documentation, systems, timelines, and study procedures.

• Monitor site progress, milestones, and pending actions within relevant clinical trial management systems.

• Collaborate with Site Activation, Regulatory, Clinical Operations, and other cross-functional teams.

• Identify and address issues that may affect site timelines.

• Aid in ongoing site maintenance efforts.

• Recognize potential delays or operational hurdles and initiate suitable follow-up actions.

• Contribute to process enhancements and disseminate best practices.

• Provide guidance and support to junior colleagues when appropriate.

⛳️ Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field, or equivalent relevant experience in clinical research.

• Previous experience in site support, site activation, study initiation, regulatory or clinical trial operations within a CRO, pharmaceutical company, or similar clinical research setting.

• Practical experience with EU CTR procedures and requirements.

• Solid understanding of clinical trial documentation, GCP, and site-level regulatory obligations.

• Proficiency in both German and English.

• Excellent written and verbal communication abilities.

• Strong organizational skills, with the capacity to independently manage multiple sites, deadlines, and competing priorities.

• A proactive, solution-oriented approach and confidence in engaging with investigator sites and cross-functional teams.

• Experience working directly with clinical trial sites in DACH is highly desirable.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related bonuses.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.