Regulatory and Start Up Specialist

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

📋 Description

• Act as the Single Point of Contact (SPOC) for investigative sites, Site Activation Manager, Project Management team, and various departments.

• Ensure compliance with SOPs, Work Instructions, quality of deliverables, and adherence to project timelines.

• Execute start-up and site activation tasks in accordance with regulations, SOPs, and work instructions.

• Distribute finalized documents to sites and internal project team members.

• Prepare site regulatory documents and verify their completeness and accuracy.

• Maintain internal systems, databases, and tracking tools with project-specific data.

• Analyze site performance metrics and communicate feedback to management.

• Develop and agree on project plans and timelines.

• Ensure monitoring protocols are established and implement contingency plans as necessary.

• Notify team members regarding the completion of regulatory and contractual documents for individual sites.

• Monitor and follow up on regulatory, ethics, ICF, and IP release documents.

• Provide local expertise to Site Activation Managers and project teams during the planning phase.

• Conduct quality control of documents submitted by sites.

• Maintain necessary activities and have direct communication with sponsors on specific initiatives.

⛳️ Requirements

• Bachelor's Degree in life sciences or a related discipline, along with 3 years of clinical research or relevant experience; or an equivalent combination of education, training, and experience.

• Proficiency in German.

• Comprehensive understanding of clinical systems, procedures, and corporate standards.

• Familiarity with GCP/ICH and relevant regulatory guidelines.

• Awareness of applicable local regulatory requirements, SOPs, and corporate standards.

• Insight into the regulated clinical trial landscape.

• Knowledge of the drug development process.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness benefits.

• Flexible work arrangements to support work-life balance.