Single Sponsor Clinical Research Associate II/Senior - Fully based in Ireland (Must have Iocal monit

Syneos Health Careers; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a dedicated Site Manager to oversee clinical research studies. The role involves managing site relationships, ensuring compliance with regulations, and monitoring trial phases. Join a passionate team committed to improving patient outcomes and driving innovation in clinical research.

Qualifications

• Experience in site monitoring within bio/pharma/CRO in Ireland.
• Fluent in local languages and English with excellent communication skills.
• Understanding of clinical research, trial phases, GCP/ICH, and local laws.

Responsibilities

• Acts as the primary site contact and site manager throughout all phases of a clinical research study.
• Develops strong site relationships and ensures continuity through all trial phases.
• Performs remote and on-site monitoring to ensure data accuracy, subject safety, and protocol compliance.

Skills

Communication

Site Management

Patient Recruitment

Education

B.A./B.S. with a focus on science or biology

Tools

MS Office

Clinical IT applications

Job description

Description

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 places the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether 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 about changing lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people through career development, progression, supportive management, technical and therapeutic training, peer recognition, and total rewards.
• We are committed to our Total Self culture, where you can be yourself. This culture unites us globally, and we prioritize taking care of our people.
• We are continually building the company we want to work for and that our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives helps create a place where everyone belongs.

Job Responsibilities

Acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites.

1. Develops strong site relationships and ensures continuity through all trial phases.
2. Performs site management activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, and associated documents.
3. Gains an in-depth understanding of the study protocol and related procedures.
4. Coordinates tasks with other sponsor roles to achieve Site Readiness.
5. Participates in site selection and validation activities.
6. Performs remote and on-site monitoring to ensure data accuracy, subject safety, and protocol compliance.
7. Conducts various site visits and documents reports promptly.
8. Monitors regulatory documentation for study start-up, maintenance, and close-out.
9. Communicates with Investigators and site staff regarding protocol conduct, recruitment, retention, deviations, and audits.
10. Addresses site performance and compliance issues, escalating as appropriate.
11. Maintains documentation in CTMS, eTMF, and other systems.
12. Acts as SME, mentor, and shares best practices within the CRA team.
13. Supports audit/inspection activities as needed.

Qualifications

What we're looking for

• B.A./B.S. with a focus on science or biology.
• Experience in site monitoring within bio/pharma/CRO in Ireland.
• Fluent in local languages and English, with excellent communication skills.
• Understanding of clinical research, trial phases, GCP/ICH, and local laws.
• Knowledge of global and regional clinical research guidelines.
• Experience with Good Documentation Practices.
• Skills in site management, performance, and patient recruitment.
• High monitoring skill level with professional judgment.
• Proficient in IT (MS Office, clinical IT applications).
• Ability to analyze data/metrics and act accordingly.

Get to Know Syneos Health

Over the past 5 years, we've worked with 94% of all FDA-approved drugs, 95% of EMA products, and over 200 studies across 73,000 sites and 675,000+ patients.

We encourage initiative and challenging the status quo in a dynamic environment. Learn more about Syneos Health.

Additional Information

Tasks and responsibilities are not exhaustive. The company may assign other duties at its discretion. Equivalent experience, skills, or education will be considered. This description does not create a contract. We comply with applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations when needed.