Clinical Studies Scientist

Job Summary

Coordinate clinical studies execution in clinical sites world-wide .

Provide support to principal investigators and their team: on-site trainings, monitoring of sites and clinical data, manage study-related administration and logistics tasks.

Ensure that studies and data management are performed in compliance with GCP, Ethical and Regulatory frame.

Key Accountabilities

•      Develop clinical study design.

•     Write clinical study protocols.

•     Write study monitoring plan.

•     Train study team on the relevant part of clinical studies

•     Ensure statistical plan is properly performed and followed.

•     Ensure data management plan is properly performed and followed.

•     Ensure study risk analysis plans is properly performed.

•     Ensure that CRFs (case report forms) are well designed, completed and collected.

•     Prepare documentation to submit project to EC/IRB (ethical Committee) and follow up with them during the study.

•     Conduct site initiation visits in the clinical sites for the purpose of training site personnel about the protocol, study         procedures, patient recruitment, reporting procedures, GCP and regulatory requirements.

•     Monitor the study throughout its duration. This activity may be done directly or managing the activity or a CRA/CRO.

•     Ensure that all study close-out activities are performed.

•     Manage clinical databases and data analysis.

•     Prepare final clinical study reports.

•     Develop all activities in compliance with GCP and under an ethical and regulatory frame.

•     Prepare study documentation for FDA pre-submissions and submissions, and for other regulatory agencies, as required.

•     Accountable for the clinical part in the projects cross-functional team

Networking/Key relationships

Mainly with R&D, Regulatory Affairs, and Design Quality and Operations colleagues

Minimum Knowledge & Experience required for the position:

Education

• Required: Bachelor's degree (Diplomatura) in Life or Medical Sciences (Medicine, Biology, Pharmacist…)
• Valuable: Any additional degree (PhD or MsC) higher than that required in the previous section

Experience:

• Minimum 4 years’ experience in scientific/in vitro diagnostic field or experience in managing clinical studies internationally

Additional Skills/Knowlwdge:

• Experience in CRF/e-CRF and other recruitment documentation
• Experience in clinical study monitoring, data management and analysis
• Knowledge of Medical Device Regulatory framework. Mainly CE and FDA
• Knowledge in GCPs
• Knowledge in immunoassay techniques and anlysers
• Knowledge in biostatistics and Data management.
• Knowledge of basic software tools (Excel, Word, PowerPoint). Knowledge of SAP prefe
• Fluency in English & Spanish.

Skills & Capabilities:

• Excellent communication (both oral and written) and analytical skills
• Able to carry out responsibilities with a high degree of independence
• Able to build cooperative relationships
• Team work
• Strong organizational and planning skills
• Flexible in handling workflow in a multi-tasking fashion
• Adaptable to a fast-changing environment
• Self-motivated and proactive
• Reflects values of Werfen and OEM in the quality of work and working relationship

Travel requirements:

Up to 15 % of time