Site Manager / CRA - Late Phase * UK *

Syneos Health Careers; London; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading biopharmaceutical solutions organization in the UK is seeking a Site Manager / CRA. The role involves site management in compliance with regulations, communication with site staff, and supporting data collection activities. Candidates should have a BA/BS in a healthcare field, strong communication skills, and at least 1 year of CRA experience. The position may require travel up to 60%.

Benefits

Career development and progression

Supportive line management

Technical training

Qualifications

• Minimum 1 year relevant CRA/SM experience required.
• Very high level of English language required.
• Knowledge of local requirements for Real World research.

Responsibilities

• Perform site management activities in compliance with regulations.
• Conduct monitoring through all study stages.
• Maintain effective communication with site staff and project team.

Skills

Excellent communication

Time management

Organizational skills

Customer service

Problem-solving skills

Education

BA/BS degree in science/health care field

Nursing degree or equivalent

Tools

Microsoft Office Suite (Word, Excel, PowerPoint)

Clinical Trial Management systems

EDC systems

Job description

Overview

Site Manager / CRA - Late Phase UK

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.

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 our Total Self culture and taking care of our people. We strive to create a diverse and inclusive environment where everyone feels they belong.

Responsibilities

• Perform site management activities in compliance with the Company and Sponsor SOPs and WIs.
• Assure compliance with local regulations and guidance depending on assigned study design/classification (may include GPP and ICH-GCP).
• Conduct site management activities per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines, including site identification, site qualification, and site start-up activities; conduct remote and on-site monitoring through all study stages.
• Review the Investigator Site File (ISF) for accuracy and timeliness; reconcile with the Trial Master File (TMF); ensure archiving of essential documents per local requirements.
• Document activities via letters, trip reports, logs, and other project documents within required timelines; support subject/patient recruitment and data tracking.
• Protect confidentiality of subject/patient information.
• Assist with data query resolution and missing data follow-up; review data using trend reports and ensure timely resolution of queries; support data collection activities with available systems.
• Maintain effective communication with site staff and project team; ensure issue escalation and resolution per SOPs, with focus on prevention.
• Maintain clinical tracking and management systems; ensure sites are trained and compliant with study protocol, informed consent, data collection tools, and safety reporting.
• Provide guidance toward audit readiness and support preparation for audits and follow-up actions.
• Prepare for, attend and participate in Investigator Meetings and sponsor meetings; collaborate with Sponsor affiliates and local country sponsor staff as required.
• Understand project scope, budgets and timelines for assigned activities; manage site-level activities and communications to meet objectives; adapt to changing priorities with supervision.
• Identify and communicate out-of-scope activities to the Clinical Operations Lead.
• Attend, contribute to and present at study and department meetings.

Qualifications

• BA/BS degree in science/health care field or nursing degree or equivalent combination of education and experience.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems.
• Minimum 1 year relevant CRA/SM experience required.
• Experience in Late Phase studies is desirable.
• Very high level of English language required.
• Excellent communication, time management, organizational, documentation and customer service skills.
• Knowledge of local requirements for Real World Late Phase study designs and Real World Research; familiarity with GPP and relevant regulations.
• Excellent customer focus and ability to interact professionally with clients and study sites.
• Willingness to work in a team-oriented environment; able to work in a virtual team or independently as appropriate.
• Ability to manage multiple tasks across studies, prioritize to meet timelines; strong problem-solving and analytical skills.
• Ability to travel up to 60% regularly, depending on assignments and study phase.

Summary

Site Monitor for UK and Ireland