DirecciónImagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives.
As part of our Clinical Operations team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need.
In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
The person in this role will provide Clinical Operations project management of dynamic and high volume study support projects across clinical studies within assigned area (e.
g., Europe) while maintaining high levels of accuracy and compliance to company policies and regulations.
How you will make an impact :
- Organize and archive documents and data in eTMF (electronic trial master file) ensuring compliance with internal procedures and regulatory guidelines.
- Conduct reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations.
Play a vital cross-functional role in TMF document retrieval and management
Identify opportunities and propose solutions to improve process efficiency within and across related functional areas (e.
g., trial workflow timelines, TMF essential documents) Develop and contribute to the creation / harmonization of templates / guidance (e.
g. document tracking tools, training materials, TMF Work Instructions). Determine root cause and recommend corrective actions on basic issues.
What you'll need :
Bachelor's Degree and 1 year of previous related experience with regulatory documentation for clinical studies are required
What else we look for :
- Good computer skills in usage of MS Office Suite and ERP software, JDE, CTMS (Clinical Trial Management System); eTMF (electronic Trial Master file) preferred.
- Strict attention to detail.
- Very good written and verbal communication skills in English are a must.
- Interpersonal relationship skills to be able to build partnerships in the organization and work in a team environment.
- Good problem-solving, organizational, analytical and critical thinking skills.
- Good knowledge and understanding of policies, procedures, and relevant (e.g., European) medical device regulatory guidelines relevant to clinical protocols
- Good knowledge of EW GDP (Global Document Practice) SOP requirements with the ability to train team members on standards and applications
- Ability to interact professionally with all organizational levels and to manage competing priorities in a fast paced environment.
- Work is performed independently on sections of projects and / or lines of work and reviewed for accuracy and soundness
- Contributes to the completion of sections of organizational projects and goals
- Develops solutions to a variety of problems of basic scope and complexity
- May participate in process improvements
What is it like to work at Edwards Lifesciences in Spain?
This is a remote role , open for people living in Spain, and some benefits included in this indefinite position are :
- Competitive Compensation and Benefits package
- Flexible working hours
- Pension plan
- Life Insurance
- Medical plan
- Service Awards
- Enhanced Leave benefits
- Employee Stock Purchase Program
- Employee Assistance Program
- Comprehensive Wellness program including gym membership reimbursement, mindfulness sessions, educational events, charity activities and much more.
Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits.
