Sponsor Dedicated Country Operations Associate - based in Spain

Reposted Yesterday
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Hiring Remotely in Barcelona, Cataluña, ESP
In-Office or Remote
Mid level
Healthtech • Biotech • Pharmaceutical
The Role
Provide operational support across site lifecycle (start-up, conduct, close-out), act as liaison among clinical teams, sites, CROs and partners; manage regulatory/ethics submissions, investigator initiation packages, document management (PTMF/eISF/CTMS), site contracting and budgets, trackers, TMF/eISF reconciliation, and quality/inspection readiness in line with ICH/GCP and local regulations.
Summary Generated by Built In
Sponsor Dedicated Country Operations Associate - based in Spain

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

Job Description Summary
- Provides operational support across the full site lifecycle: Start-Up, Conduct, and Close-Out.
- Acts as a key contact between clinical teams, investigator sites, CROs, and external partners.
- Supports Regulatory Authority (RA), Ethics Committee (EC/IRB/LEC) submissions and associated documentation.
- Prepares and maintains Investigator Initiation Packages (IIPs) and essential study documents.
- Performs document management activities in PTMF, eISF, CTMS, and document exchange systems.
- Supports site contracting and budget processes, including tracking negotiations and execution status.
- Maintains study trackers, timelines, and task status to ensure visibility of risks and progress.
- Reviews study and site files for completeness and supports TMF/eISF reconciliation activities.
- Contributes to quality, inspection readiness, compliance, and continuous improvement initiatives in accordance with ICH/GCP and local regulations.
Qualifications
- Requires 2-5 years of experience in site activation, clinical trial support, or clinical operations, with strong organizational and communication skills.
- BS/BA or bachelor’s degree in life sciences or a related discipline is an asset

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://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Skills Required

  • 2-5 years experience in site activation, clinical trial support, or clinical operations
  • Experience with document management in PTMF, eISF, CTMS, or document exchange systems
  • Experience supporting Regulatory Authority (RA) and Ethics Committee (EC/IRB/LEC) submissions
  • Experience preparing and maintaining Investigator Initiation Packages and essential study documents
  • Experience with site contracting and budget tracking/negotiation processes
  • Strong organizational and communication skills
  • Knowledge of ICH/GCP and local regulatory requirements and inspection readiness
  • BS/BA or bachelor's degree in life sciences or related discipline (asset)

Syneos Health Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Syneos Health and has not been reviewed or approved by Syneos Health.

  • Leave & Time Off Breadth Unlimited PTO for managers and flexible time‑off options make time away accessible and support work‑life balance. Day‑to‑day usability can depend on team and workload, but the policy breadth is a clear strength.
  • Retirement Support A 401(k) with company match is frequently highlighted as a strong component of the package. Despite vesting details to confirm, the retirement offering adds meaningful long‑term value.
  • Parental & Family Support Partnership with Maven provides fertility, adoption support, parental‑leave guidance, and women’s health resources across multiple regions. This family‑building support enhances the overall total rewards appeal.

Syneos Health Insights

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The Company
HQ: Raleigh, NC
22,543 Employees

What We Do

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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

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