RWE Associate Site Manager, German Language

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

📋 Description

• Accountable for overseeing remote site monitoring and facilitating study delivery activities.

• Completes necessary training related to therapeutic areas, protocols, and clinical research.

• Collaborates effectively with other departments, including the Clinical Operations Lead (COL), Project Management, Data Management, and Safety teams.

• Aids in the onboarding process of sites during the study delivery phase.

• Conducts initiation, remote monitoring, and close-out activities as required.

• Acts as the primary liaison between the organization and the investigator site.

• Works jointly with field Clinical Research Associates (CRAs) to identify, address, and document site-related issues.

• Evaluates the quality and integrity of patient data at designated sites.

• Ensures prompt transmission of clinical data and collaborates with sites to resolve any data queries.

• Facilitates data cleaning and prepares for database lock.

• Provides feedback and updates to the assigned COL regarding site performance.

• May assist with and participate in Investigator Meetings and site engagement initiatives.

⛳️ Requirements

• Preferred Bachelor's Degree in a scientific discipline or healthcare, or as mandated by local policies.

• At least 1 year of relevant clinical experience is preferred.

• Pre-intermediate understanding of clinical research processes and medical terminology.

• Familiarity with the study execution and delivery lifecycle.

• Strong written and verbal communication skills, including proficiency in the English language.

• Excellent organizational and problem-solving abilities.

• Capability to manage multiple priorities across various sites and studies.

• Ability to meet deadlines and follow project timelines.

• Competence to work independently on routine tasks and apply critical thinking with guidance as necessary.

• Skill in establishing and maintaining effective relationships with sites, colleagues, and stakeholders.

• Knowledge of electronic data capture (EDC) systems and data review processes.

• Pre-intermediate knowledge of ICH-GCP guidelines and relevant regulations.

• Understanding of different study designs and their operational implications.

• Proficient in computer applications, including Microsoft Word and Excel.

🏝️ Benefits

• Health and welfare benefits.

• Opportunities for professional development.

• Alignment of site payment activities with study progress.