Associate Analyst, Clinical Operations

hace 3 meses

Valencia, España Edwards Lifesciences A tiempo completo

The Associate Analyst in the Clinical Operations team will ensure Edwards Clinical Studies documentation provides a valid source of traceability and accountability data for regulatory submissions, reporting, and audits while maintaining high levels of accuracy and compliance to company policies and regulations. He/she will provide support to team members and aligns teamwork to harmonize department policies. The role is remote for Spain and the starting date is September.

Key Responsibilities
- Organize and archive documents and data in eTMF (electronic trial master file) ensuring compliance with internal procedures a nd regulatory guidelines.
- Identify and assess TMF issues and/or discrepancies discovered during review and collaborate with appropriate team members to bring to resolution
- 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
- 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
- Follow-up with audit finding owners to ensure that audit and/or inspections findings are addressed, and issues resolved in collaboration with team members (e.g., Clinical Compliance)
- Process payments/expenses and maintain payment tracker per company requirements (Coupa).
Education and Experience
Bachelor's Degree or Professional Education required
1 year experience of previous related experience with regulatory documentation for clinical studies required

Additional Skills
- Very 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
- Good problem-solving, organizational, analytical and critical thinking skills
- Ability to manage competing priorities in a fast paced environment
- Good written and verbal communication skills and interpersonal relationship skills
- Ability to interact professionally with all organizational levels and build stable working relationships internally. Be able to work in a team environment, including immediate supervisor and other team members in the section or group
- Good knowledge and understanding of policies, procedures, and relevant (e.g., European) medical device regulatory guidelines relevant to clinical protocols
- Contributes to the completion of sections of organizational projects and goals and develops solutions to a variety of problems of basic scope and complexity
- Errors in judgment or failure to achieve results may require some expenditures of resources to rectify

What is it like to work at Edwards Lifesciences in Spain ?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment. We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on
- the - job development, training opportunities and the support and guidance provided by dedicated employee groups ( the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others ).

Edwards Lifesciences in Spain also offers the following benefits:
Competitive Compensation and Benefits package

Flexible working hours, remote working

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. Benefits policy and components may vary by location.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.

For us, helping patients i

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