Descripción de la oferta
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…)
Degree may be substituted by relevant skills and work experience.
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/Knowledge:
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.
Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading, speaking and writing )
Skills & Capabilities:
Attention to detail and accuracy
Able to apply general scientific methods and theoretical knowledge to tasks within one area of expertise.
Teamwork and interpersonal skills. Flexibility in order to work with, and provide support for a number of people.
Oral and written communication skills.
Time management skills. Excellent organizational and multi-tasking skills.
Thorough knowledge of design control processes and familiarity with quality standards as required.
Excellent analytical skills.
Able to work independently on the project with moderate guidance.
Well organized, able to handle large data sets, and communicate results, problems, and progress to the supervisor, and within the group as required.
Ability to adapt to R&D flexible and changing environment.
Certain troubleshooting ability required.
Reflects values of Werfen and OEM in the quality of work and working relationship.
