Senior Site Activation & SSU specialist. Experience submitting GMO studies to Genetically Modif[...]

Location : Spain-Europe - ESP-Home-Based (Barcelona)

Job ID : 25002107

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Job Responsibilities :

1. Prepare and present clinical trial applications through the Clinical Trials Information System (CTIs).
2. Manage the documentation and certifications required for studies involving Genetically Modified Organisms (GMO).
3. Proven experience in presenting clinical studies to CTIs.
4. Deep knowledge and proven experience of regulatory requirements for GMO studies.
5. Ability to work under pressure and meet tight deadlines.
6. Effective communication skills and ability to facilitate team collaboration.

Qualifications :

1. Bachelor’s Degree
2. Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
3. Good understanding of clinical protocols and associated study specifications
4. Excellent understanding of clinical trial start-up processes
5. Project management experience in a fast-paced environment
6. Strong organizational skills with proven ability to handle multiple projects
7. Excellent communication, presentation and interpersonal skills
8. Quality-driven in all managed activities
9. Strong problem-solving skills
10. Ability to mentor, lead and motivate more junior staff
11. Demonstrate an ability to provide quality feedback and guidance to peers
12. Mandatory Spanish and English fluent

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.