Description
Clinical Data Reviewer (US and UK Only)
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 centers on the customer and the patient. 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 therapy delivery because we are passionate about changing 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, progression, supportive management, training, peer recognition, and rewards.
- We are committed to our Total Self culture, where you can be authentic. We focus on diversity of thoughts, backgrounds, and perspectives to foster a sense of belonging.
Job Responsibilities
- Remote Role: Open to UK and all US - No sponsorship available.
The Clinical Data Reviewer (CDR) may be responsible for reviewing clinical data of one or more studies, with flexibility to move between projects. The CDR should possess comprehensive knowledge of the therapeutic area to ensure data validity, especially for complex phase 3 trials with large datasets, supporting milestones like interim and final analyses, submissions, and publications. Review tasks include point-to-point data checks and interpretive analysis to identify inconsistencies and safety signals. The CDR will develop and utilize best practices and tools for data review, following SOPs and regulations, and seek continuous improvement in quality and efficiency.
Qualification Requirements
- Bachelor's degree in life sciences, drug development, or business; advanced degrees are a plus.
- Understanding of data review and quality assurance processes.
- Experience in clinical research, especially in phase 3 studies, with a record of successful regulatory submissions.
- Strong technical skills in reviewing large datasets, familiar with Oracle Clinical, InForm EDC, and data management concepts.
- Proficiency in Excel and basic knowledge of data interactions and analysis impact.
- Ability to work independently and collaboratively, prioritize tasks, and adapt to changing deadlines.
- Access to CITRIX platform (JReview) and tracking tools in Excel is required.
Get to know Syneos Health
Over the past 5 years, we worked with 94% of all FDA-approved drugs, 95% of EMA products, and conducted over 200 studies across numerous sites and patients.
Join us in challenging the status quo in a dynamic environment. Learn more athttp://www.syneoshealth.com
Additional Information
This job description is not exhaustive; tasks may vary. Qualifications considered equivalent will be evaluated at the company's discretion. Nothing herein creates an employment contract. We comply with applicable legislation, including the EU Equality Directive and the ADA, providing accommodations as needed.
Summary
The role involves reviewing participant data in accordance with the Data Review Plan and coordinating with the Lead Clinical Scientist. Data reviewed may include safety, efficacy, or other areas as delegated.
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