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

📋 Description

• Conduct activities in alignment with relevant Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions.

• Support Clinical Monitoring personnel with site management tasks and act as a representative for the Sponsor at designated study sites.

• Engage with sites to guarantee adherence to protocol stipulations, study methodologies, and pertinent guidelines.

• Develop and preserve project documentation and manage project-related correspondence.

• Participate in audits of files.

• Create and update site manuals, reference materials, and additional documentation.

• Maintain, refresh, and enter clinical tracking data into databases.

• Monitor the flow of incoming and outgoing clinical and regulatory documents and their updates.

• Oversee a shared mailbox, manage site requests, and appropriately route correspondence.

• Coordinate the ordering, packaging, shipping, and tracking of supplies and materials for sites.

• Assist in coordinating team meetings, attend those meetings, and prepare meeting minutes along with action items.

• Proactively identify and address potential issues; implement corrective measures as necessary.

• Complete mandatory clinical research training.

• May offer training or mentorship to junior Clinical Operations Specialists.

⛳️ Requirements

• An associate's degree is preferred or equivalent experience.

• Relevant experience in clinical research, pharmaceuticals, biotechnology, or a related field may be accepted in place of a degree.

• Preferred knowledge of medical terminology, clinical data, and ICH/GCP guidelines.

• Ability to effectively prioritize and manage multiple tasks concurrently.

• Strong attention to detail, precision, and organizational capabilities.

• Excellent communication, presentation, and interpersonal abilities.

• Willingness to adopt new technologies.

• Minimal travel of up to 10% may be necessary.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• Emphasis on a Total Self culture.

• Initiatives focused on diversity, inclusion, and belonging.