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AI Summary
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
RESPONSIBILITIES:
- Performs study activities including start-up, maintenance and close-out with other Clinical Operations team members’ oversight and guidance.
- Performs eTMF functional QC and CRO oversight QC. (PMS)
- Performs study document upload to Trial Master File or other repositories.
- Reviews and participates in the quality assurance of data or documents.
- Assists with development of documents and standard forms.
- Arranges study meeting logistics, agendas, and assists with minutes (including PMS global study team meeting)
- Tracks and prepares study-specific information using databases, spreadsheets, and other tools.
- Maintains internal Clinical Operations databases, Tools and document repositories
- Provides administrative support for study-related activities under the supervision of Clinical Operations team members
- May act as a local subject matter expert (SME) or SPOC for a specific focus area e.g. eTMF/TMF, CTMS, budget, document archiving, etc.
- Interacts with other departments, as needed, to complete assigned tasks.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
REQUIREMENTS:
- Minimum Education & Experience
- Mandatory: 1 or more years’ relevant work experience – SSU (Study Start-up) or CTA (Clinical Trial Assistant) from Pharma/CRO or Study Coordinator from investigational sites.
- BA / BS / RN
- Some general clinical or business knowledge and experience is preferred.
- Knowledge & Other Requirements
- Knowledge of local country regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures
- eTMF, CTMS & SSU(A) experiences preferred.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Understands how to use basic office programs / tools.
- Ability to communicate in a clear and concise manner.
- Ability to support a team-oriented, highly-matrixed environment.
- Ability to execute multiple tasks as assigned
- Excellent verbal and written in Korean and English skills, and interpersonal skills are required.
- Works proactively under minimal supervision.
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 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.
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