Jobs in Warwick, United Kingdom

Updated: Today 
Location: GBR-Remote
Job ID:25101909

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

Our Clinical Development model places the customer and 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 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.

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 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 – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

• Perform site management activities in compliance with the Company and Sponsor (if applicable) Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Assure compliance with local regulations and appropriate guidance depending on assigned study design / classification. May include Good Pharmacoepidemiology Practices (GPP) and/or International Conference on Harmonization Good Clinical Practice (ICH-GCP).
• Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines. Site identification – may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc.; Site Qualification; Ensures selection of appropriate sites for assigned studies; Site Start-Up – with minimal supervision, ability to perform activities for assigned sites working with study start-up and regulatory; Conduct of all remote and on-site monitoring activities through all study stages.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and SMP, within required timelines. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assigned sites data review, assisting with data query resolution and missing data follow-up (only as applicable). Review data using data trend reports and knowledge of site practices. Ensure the resolution of data queries within agreed timelines. Utilize available hardware and software to support effective study data collection and review.
• Maintain effective, accurate and timely communication with site staff and project team, and ensure appropriate issue escalation and resolution as per SOPs with a focus on issue prevention.
• Maintains clinical tracking and management systems.
• Ensure all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools and safety reporting.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Prepare for, attend and participate in Investigator Meetings and/or sponsor face-to-face meetings.
• As required, collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Clinical Operations Lead or designee, to changing priorities to achieve goals / targets.
• Identify and communicate out of scope activities to Clinical Operations Lead.
• Attend, contribute to and present at study and department meetings.

• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
• Must be proficient in Microsoft Office Suite (Word, Excel, and 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 is required.
• Excellent communication, time management, organizational, documentation and customer service skills.
• Knowledge of local requirements for Real World Late Phase study designs as well as Real World Research and relevant regulations including GPP.
• Excellent customer focus (internal and external) and able to interact professionally with a client organization and study site.
• Willingness to work within a team-oriented environment. Ability to work in a “virtual” team setting as well as work independently, seeking guidance as appropriate.
• Ability to handle multiple tasks (across multiple studies as necessary) and prioritize accordingly to achieve study timelines. Sound problem solving and analytical skills.
• Excellent command of written and spoken local language, if not English, as well as English required.
• Ability to develop good working relationships via oral communication and good phone etiquette.
• Ability to travel up to 60% on a regular basis depending on assignments and study phase.

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.

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. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com. One of our staff members will work with you to provide alternate means to submit your application.