Clinical Support Specialist II

Clinical Support Specialist II 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 Summary The position is responsible for providing operational and administrative support, with limited supervision, to one or more clinical functions, including but not limited to Project Management, Site Management, Data Management, Biostatistics, Medical Writing, Site Selection, Site Activation, Site Contracting, and Regulatory clinical trials submissions. Accountable to functional leads for project level deliverables, and to line manager for performance across projects.

Core Responsibilities • Responsible for providing operational and administrative support to one or more clinical functions. • Responsibilities may include but are not limited to: • Provide administrative support by coordinating documentation and communications, including maintaining and managing shared mailboxes, organizing project files, tracking action items, and ensuring timely follow-up with cross-functional stakeholders. • Enter, maintain and reconcile information in agreed project and clinical tracking systems. • Timeline and milestone tracking. • Perform document management activities including document creation, compilation, formatting, version control, and quality control (QC). • Translation of documents using approved vendors/systems • Use AI-enabled tools, dashboards, and automated reports to provide logistical, organizational, and analytical support • Support Trial Master File (TMF) filing and related document process activities within scope, ensuring inspection-ready documentation. • Responsible for providing quality deliverables. Follow project requirements and applicable country rules, with oversight at the project level from functional leads. • Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting. • Monitor workload/scope, budgeted effort, and project hours; escalate discrepancies in a timely manner • Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

Qualifications: • Associate’s degree or equivalent combination of education, training and experience. • 1 to 2 years of clinical operations experience • Provide operational and administrative support to CRAs and Country Regulatory Specialists within the site activation and regulatory submissions functions. • Must have experience with Local Packages (Ethics Committee) submissions. • Site/Study startup experience (part of operations). • Good understanding in clinical research, drug discovery, clinical trials (setup, maintenance, closeout). • Must have good communication (Verbal & Written) • Demonstrated understanding of clinical operations • Utilize problem-solving techniques effectively • Strong documentation and communication skills (written and spoken English) as well as a team[1]oriented approach. • Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher) and ability to embrace new technologies and demonstrate ability to learn and adopt new technologies and tasks (including AI-enabled tools and dashboards where approved/available). • Ability to manage competing priorities and work in a dynamic fast-paced environment. • Demonstrated ability to work independently as well as part of a team • Good organizational skills and attention to detail, proven ability to take direction from multiple individuals and set priorities accordingly. • Quality-driven in all assigned activities. • Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.

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.