Job Description

Description

Senior Clinical Operations Specialist - Single Sponsor (UK based - fully home based)

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.


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. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions


Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines


Creates and assists with maintenance of project files, handles project correspondence


Participates in file audits


Prepares and maintains site manuals, reference tools and other documents


Maintains, updates, and inputs clinical tracking information into databases


Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client


Manages shared mailbox, processes site requests and routes correspondence appropriately


Coordinates the ordering, packaging, shipping and tracking of site supplies and materials


Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items


Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues


Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.


May provide training or mentorship to more junior level Clinical Operations Specialists (COS).
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Qualifications

What we're looking for

Associates degree preferred or equivalent


Experience in clinical research/pharma/biotech or related field considered In lieu of degree


Good knowledge of medical terminology, clinical data, and ICH/GCP preferred


Ability to successfully prioritize and work on multiple tasks


Strong attention to detail, accuracy and organizational skills


Excellent communication, presentation, and interpersonal skills


Ability to embrace new technologies


Minimal travel up to 10% may be required

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

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 . 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.


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