Clinical Site Lead (EMEA)

La experiencia que se espera de los solicitantes, así como las habilidades y cualificaciones adicionales necesarias para este trabajo, se enumeran a continuación.

Role Summary

The Clinical Site Lead drives study execution, operational excellence, and site management across multiple therapy areas in accordance with local and international regulations. This role is a recognized subject matter expert in clinical working instructions, clinical investigation plans, and product/disease state throughout the full study lifecycle, from startup through closeout.

Key Responsibilities

- Acts as the primary point of contact, internally and externally, for assigned study sites.
- Coordinates, implements, and executes clinical studies within assigned country/region.
- Identifies, develops, and maintains sites capable of delivering startup goals, study participation levels, and required data quality.
- Identifies appropriate investigators, completes qualification processes, and establishes site/sponsor expectations for study execution.
- Facilitates all aspects of the site startup process, coordinating with Site Operations teams to ensure activation and enrollment within timelines.
- Develops site-specific strategies to promote appropriate patient enrollment.
- Attends study procedures and follow-ups as required per study-specific requirements.
- Monitors clinical studies at sites to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards, including initiation, periodic, and closeout visits.
- Reviews data and source documentation from investigational sites for accuracy and completeness; provides timely feedback to sites.
- Leads, initiates, and coordinates activities to ensure clinical study and regulatory compliance,



including Key Compliance Indicator reporting and audit support.
- Ensures adverse events, device complaints, and protocol deviations are reported in a timely manner per regulations and standard procedures.
- Resolves and/or facilitates resolution of site issues, including root cause analysis and preventive actions; reports monitoring visit findings per required timelines.
- Trains and retrains site personnel to ensure compliance with the study protocol and local regulations.
- Provides continuous updates on study and site progress to Clinical Operations and Study Management.
- Contributes to site budget discussions and coordinates with contracts associates on contract execution.

Required Qualifications

- Background in engineering, science, health science, nursing, or a related field; or equivalent experience in cardiology or clinical research.
- Minimum 4 years of relevant experience in clinical research and/or clinical site management.
- Fluency in English (written and verbal) and local/country language.
- Proficiency in MS Office and clinical database systems (Oracle preferred).
- Expert knowledge of GCPs and regulatory compliance guidelines for clinical trials (applicable ISO standards, FDA regulations).
- Expert knowledge of clinical study conduct, follow-up, and monitoring.
- Advanced knowledge of clinical and outcomes research study design.
- Strong communication, prioritization, organizational, and time management skills.
- Proficient knowledge of medical terminology.
- Ability to work independently and within a team in a fast-paced, matrixed environment.
- Ability to travel at least 70%, including internationally.

Preferred Qualifications

- Additional European language skills. xqbhyrx
- Experience working in a cross-division or enterprise business unit model.

Terms & Start

- 12+ month contract
- Remote - travel to clinical sites within region

📌 Clinical Site Lead (Córdoba)
🏢 GForce Life Sciences
📍 Córdoba