3 publicaciones de empleo destacadas de clinical associate en spain (¡Están contratando!)

Lead Clinical Research Associate
United Biosource Corporation —España
- Teletrabajo
- Inglés
- Microsoft Office
- Grado
Solicitud rápida
9d
Associate Feasibility Strategist- Remote
Thermo Fisher Scientific —España
- Jornada completa
- Teletrabajo
- Microsoft Powerpoint
- Microsoft Excel
- Informática
Study Start Up Lead
Rho Inc —España
- Jornada completa
- Teletrabajo
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Solicitud rápida

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Associate Feasibility Strategist- Remote
Thermo Fisher Scientific —España
Industry experience (pharmaceutical R&D or related industry) with direct experience in clinical trials operations, data management, study feasibility or project…

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Lead Clinical Research Associate

United Biosource Corporation -
España

Solicitud rápida

Detalles del empleo

Hace 9 días

Cualificaciones

Inglés
Microsoft Office
Grado
Liderazgo
Gestión del tiempo

Descripción completa del empleo

As a pharmaceutical support industry leader, UBC is dedicated to empowering health solutions for a better tomorrow. We are committed to improving patient outcomes and advancing healthcare. At UBC, we offer services that enhance the entire drug development process and commercialization lifecycle, from clinical trial support to real-world evidence generation.

Join us at UBC for a rewarding career journey as a Lead Clinical Research Associate where you can grow professionally while making a meaningful impact on the world around you. Our culture is rooted in our Core Values of Collaboration, Conscientiousness, Curiosity, Compassion, and Consultation, fostering an inclusive workplace that encourages creativity.

If you are looking for a career that will challenge, inspire, and reward you, consider joining our team at UBC. Apply now to be part of our mission to drive innovation in healthcare and make a difference in patients' lives.

Brief Description:

Provides clinical project oversight and support to the project management (PM) team. Provides oversight and manages clinical monitoring and site management portions of projects in accordance with ICH/GCP, CFR guidelines, regional or country regulations/ legislations, as well as UBC and sponsor SOPs.

Specific job duties:

Thorough knowledge of sponsor specific project requirements, scope, protocol and timelines
Provides oversight of the day-to-day clinical operations of US, European and/or multi-national global projects from start-up through close-out
Reviews and approves monitoring reports and letters within UBC and/or sponsor timelines
Leads and assists with UBC and project specific training
Ensures appropriate visit scheduling per protocol; tracks, reports and escalates adherence to site visit schedule, trip report metrics and documentation of completed tasks
Provides oversight of the issues & actions and protocol deviations to ensure timely resolution per UBC and/or sponsor timelines
Serves as primary liaison for monitoring issues, escalating to PM and/or Evidence Development Operations (EDO) Manager when appropriate
Assists with preparation and leading of sponsor, project team and UBC meetings
Assists as back-up for PM and may be primary contact for UBC/sponsor interaction
Collaborates with PM to provide input into resourcing, analyzing cost variances, out-of-scope management, and conducting revenue recognition as applicable
Coordinates site assignments for team in conjunction with PM and EDO Manager
Monitors clinical operations aspects of the project against the established plans, SOPs and KPIs ensuring compliance
Assists PM with the creation and maintenance of project specific documents
Responsible for maintenance of audit-ready project systems (eTMF, CTMS, project specific systems) as related to clinical operations
Mentors and supports project team
May include reviewing the preparation, submission and tracking of Competent Authority (CA), Central and Local Ethics Committee and other regulatory applications, as per country requirements
May include oversight of contract negotiation activities with the sites as per country requirements
May be required to perform site monitoring as needed.
May review and provide oversight of study feasibility assessments
May assist PM and EDO Manager with management of Vendor CRAs
May require up to 30% travel
Assists with other duties as assigned

Supervisory Responsibility:

Desired Skills and Qualifications:

Bachelor’s degree in Health Care/Life Science preferred or equivalent industry experience

Minimum of 5+ years of site management experience required with preference of 2 years field monitoring experience
Knowledge and understanding of the local country laws applicable to clinical trials and observational studies
Proficient in the operational methodologies of clinical trials and observational studies
Thorough knowledge of medical terminology, ICH/GCP and UBC SOPs
Excellent written and verbal communication skills in English and local language
High attention to detail
Excellent critical thinking and resolution skills
Displays leadership, organizational, communication, time management and interpersonal skills
Proven skills with CTMS, eTMF, EDC, Microsoft Office, basic computer software and sponsor specific systems
Ability to work independently and within a cross-team environment.
Confident in taking responsibility for operational day-to-day project oversight
Ability to coordinate monitoring project activities at local, national, and international studies

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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