Global CTA. Regulatory . Sponsor dedicated

Puesto: Global CTA. Regulatory experience. Location Sponsor dedicated.
Global CTA. Regulatory experience.

Location:

Barcelona. Sponsor dedicated.

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities The CTA is a Clinical Trials Technician responsible to provide support to the Regulatory Affairs Global team.

Specific tasks:

Main tasks:

Pre-submission/submission/post-submission

Download Validation/Conclusion/Decision Data Fields/List of Approved Documents and Notify for Archiving in TMFUpdate Internal Timelines Tracker:

Notifications and Database Updates:

Send notifications based on specific triggers (e.g., changes in data, approvals, or submissions). Update the internal submission tracker and report any relevant information to the database.

Site Reports:

Filter Excel files related to site information. Verify data against official sources (such as the World Health Organization). Follow up with the CTL or Project Specialist as needed.

Data Fields and Translations:

Request translations for specific data fields if necessary.

Submission Timelines Check:

Verify that submission timelines align with project requirements.

Backlog Archiving:

Address any backlog related to archiving documents or data .

Qualifications:

High School diploma or equivalent

Excellent communication skills, highly committed, detail-oriented, meticulous, and exceptionally well-organized. Demonstrates a positive attitude, openness and transparency, strong collaboration skills, and the flexibility to adapt effectively within a team environment.

Ability to embrace new technologies

Experience in Veeva and CTISEnglish very high level

Minimal travel up to 25% may be required

Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.http://(Usted puede enviar una solicitud o contactar con nosotros por email usando el Buzón de Solicitud online de abajo) Additional Information Tasks, duties, and responsibilities as listed in this job…