Associate Analyst, Clinical Operations

hace 2 semanas

Valencia, España Edwards Lifesciences A tiempo completo

Imagine 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
- 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.

  • Security Operations Analyst

    hace 6 días

    Manises, Valencia provincia, España Quanta A tiempo completo

    Security Operations Analyst, remote or onsite in Valencia, Spain Our client, an international IT service provider, is seeking a Security Operations Analyst to join them as a contractor, with the option to work fully remote or onsite. This will be a long running contract with regular 6 month contract periods. Interviews will take place in March 2024 for a...

  • Sales Operations Analyst

    hace 4 semanas

    Valencia, España Groupon A tiempo completo

    Groupon’s mission is to become the daily habit in local commerce and fulfill our purpose of building strong communities through thriving small businesses by connecting people to a vibrant, global marketplace for local services, experiences, and goods. In the process, we’re positively impacting the lives of millions of customers and merchants globally....

  • Ventures Analyst Valencia Talent Team

    hace 4 semanas

    Valencia, España Plug and Play Tech Center A tiempo completo

    **Plug and Play** is the ultimate innovation platform, bringing together the best startups and the world’s largest corporations. We are on a mission to bring the benefits of Silicon Valley to all four corners of the world. Our vision is to make innovation open to anyone, anywhere. The **Venture Analyst** role is a **key entry level position** on the...

  • Senior Trade Analyst

    hace 4 semanas

    Valencia, España Alchemy Global Talent Solutions A tiempo completo

    A Leading Organisation are looking for a Senior Trade Analyst to join their team in Spain. **Responsibilities;** - Processing all customs data into the customs system - Preparing customs information in accordance with international trade - Manage special customs procedures, as required e.g. temporary imports, returned goods, samples. - Provide support for...

  • Senior Trade and Customs Analyst

    hace 4 semanas

    Valencia, España Alchemy Global Talent Solutions A tiempo completo

    A Leading Organisation are looking for a Senior Trade and Customs Analyst to join their team in Spain. **Responsibilities;** - Processing all customs data into the customs system - Preparing customs information in accordance with international trade - Manage special customs procedures, as required e.g. temporary imports, returned goods, samples. - Provide...

  • Business Operations Sr. Analyst

    hace 2 semanas

    Valencia, España Edwards Lifesciences A tiempo completo

    Initiates, plans, partners with functions, executes, controls and manages all aspects to ensure operational excellence Key Responsibilities: I. Lead improvement of operational processes in the commercial organization: Leads mid-large scale commercial excellence projects and initiatives to increase efficiency of the commercial, such as: Inventory...

  • Business Operations Sr. Analyst

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Initiates, plans, partners with functions, executes, controls and manages all aspects to ensure operational excellenceKey Responsibilities:I. Lead improvement of operational processes in the commercial organization: Leads mid-large scale commercial excellence projects and initiatives to increase efficiency of the commercial, such as: Inventory management...

  • Analyst, Operations Quality

    hace 4 semanas

    Valencia, España Celestica A tiempo completo

    Req ID: 120065 Remote Position: Hybrid Region: Europe Country: Spain State/Province: La Pobla De Vallbona City: Valencia **Long Description**: **Company: Celestica Valencia S.A.** Celestica is a Canadian company, world leader in the electronic manufacturing sector. The plant in Valencia focuses its activities in the Aerospace, Industrial and Healthcare...

  • Associate Cybersecurity Operations Administrator

    hace 4 semanas

    Valencia, España UNICC A tiempo completo

    **Purpose of the Position**: The incumbent will provide support and guidance to UNICC and its partner organizations in relation to the Vulnerability Management Service and related activities. **Objectives of the Programme**: The objective of the Centre is to provide trusted ICT services and digital business solutions to its Clients and Partner...

  • Ventures Analyst Health

    hace 4 semanas

    Valencia, España Plug and Play Tech Center A tiempo completo

    **Who we are** Plug and Play is the ultimate innovation platform, bringing together the best startups and the world’s largest corporations. We are on a mission to bring the benefits of Silicon Valley to all four corners of the world. Our vision is to make innovation open to anyone, anywhere. The** Venture Analyst** role is a key entry level position on...

  • ICT Associate

    hace 3 semanas

    Valencia, Valencia, España United Nations Office for Project Services A tiempo completo

    Job DescriptionDescription –>The Service for Geospatial, Information and Telecommunications Technologies at the UNGSC provides a critical role as the as the resilient operational hub for the support and delivery of technology services and solutions to field operations and a broad range of Secretariat and United Nations system clients. As a unified,...

  • ICT Associate

    hace 2 semanas

    Valencia, Valencia, España United Nations Office for Project Services A tiempo completo

    Job DescriptionDescription –>The Service for Geospatial, Information and Telecommunications Technologies at the UNGSC provides a critical role as the as the resilient operational hub for the support and delivery of technology services and solutions to field operations and a broad range of Secretariat and United Nations system clients. As a unified,...

  • ICT Associate

    hace 3 semanas

    Valencia, España UNOPS A tiempo completo

    **** THIS IS A LOCAL POSITION FOR WHICH ONLY APPLICANTS WHO ARE SPANISH OR EUROP... The New York Portfolios Office (NYPO) supports the United Nations Secretariat, as well as other New York-based United Nations organizations, bilateral and multilateral partners in the delivery of UNOPS mandate in project management, infrastructure management, and...

  • Ventures Analyst

    hace 4 semanas

    Valencia, España Plug and Play Tech Center A tiempo completo

    **WHO WE ARE**: Plug and Play is a global innovation platform and venture capital firm. Our mission is to make innovation open to anyone, anywhere. Each year, hundreds of entrepreneurs join our vertical-specific accelerator programs to team up with our corporate members or receive a direct investment from Plug and Play. Plug and Play has over 40 locations...

  • Ventures Analyst I Travel

    hace 4 semanas

    Valencia, España Plug and Play Tech Center A tiempo completo

    **WHO WE ARE**: Plug and Play is a global innovation platform and venture capital firm. Our mission is to make innovation open to anyone, anywhere. Each year, hundreds of entrepreneurs join our vertical-specific accelerator programs to team up with our corporate members or receive a direct investment from Plug and Play. Plug and Play has over 40 locations...

  • ICT Associate Linux and Automation

    hace 3 semanas

    Valencia, Valencia, España United Nations Office for Project Services A tiempo completo

    Job DescriptionDescription –>The ICT Associate [Linux and Automation] will carry out his/her tasks within the Platform Support Unit in the Field Technology Service (FTS) at the UN ICT Facility, Valencia (UNICTFV). Provides specific expertise in the implementation and operation of the UN Hybrid Cloud strategy for the back end infrastructure including:...

  • Ventures Analyst I Energy

    hace 4 semanas

    Valencia, España Plug and Play Tech Center A tiempo completo

    **WHO WE ARE**: Plug and Play is a global innovation platform and venture capital firm. Our mission is to make innovation open to anyone, anywhere. Each year, hundreds of entrepreneurs join our vertical-specific accelerator programs to team up with our corporate members or receive a direct investment from Plug and Play. Plug and Play has over 40 locations...

  • Ventures Analyst I Energy

    hace 4 semanas

    Valencia, España Plug and Play Tech Center A tiempo completo

    **WHO WE ARE**: Plug and Play is a global innovation platform and venture capital firm. Our mission is to make innovation open to anyone, anywhere. Each year, hundreds of entrepreneurs join our vertical-specific accelerator programs to team up with our corporate members or receive a direct investment from Plug and Play. Plug and Play has over 50 locations...

  • Analyst Ii Business Process Transactions

    hace 4 semanas

    Valencia, España DXC Technology A tiempo completo

    Partners with the businesses to ensure that the capital strategies are operationally supported and strategically focused to secure the greatest return on investment for the global company. Gathers financial data and performs financial analyses and reporting (e.g., profit & loss, balance sheet, cash flow, pricing, etc.) to influence decisions within the...

  • Data Team Lead/Senior Data Team Lead

    hace 1 semana

    Valencia, Valencia, España IQVIA A tiempo completo

    IQVIATM is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to...