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 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
- Remote Role: Open to UK and all of US - No sponsorship is available.
- The CDR may be responsible for the clinical data review of one or more studies with the ability to move easily from project to project as necessary.
- The CDR has comprehensive knowledge and understanding of the therapeutic area under study and uses that knowledge to ensure that patient data are scientifically and clinically valid. The studies supported by the CDR are often, but not exclusively, complex comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets In addition the CDR ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications.
- Review tasks performed by the CDR include both point-to-point data checks (e.g., verifying the presence of a blood pressure value that satisfies study inclusion criteria) and interpretive analysis (e.g., evaluating subject to find inconsistencies the patient’s data).
- The CDR will create and use data review best practices and associated data review tools to identify trends and any safety signals.
- Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
Qualification Requirements
- Bachelor’s degree in one of the disciplines related to life sciences, drug development or business. Advanced degree is desirable.
- A thorough understanding of the processes associated with reviewing and delivering quality data.
- Strong field monitoring experience an asset
- Deep Clinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor and with a track record of successful regulatory submissions
- Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines.
- Familiar with Oracle Clinical Remote Data Capture and/or other database systems; technically competent with Microsoft Excel and ideally, Access.
- Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.
- Prior InForm EDC experience a must or very quick learner for data platform technology systems
- Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)
- Moderate level of tech savvy to learn new systems quickly and to be able to navigate independently in different systems
- Basic understanding of how data points from different field/CRFs interact and how data collection impacts analysis
- Strong attention to detail
- Ability to work independently and as part of team
- Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)
- Access to internal CITRIX platform (JReview) will be required to obtain data review listings
- Review tracking required (Excel format)
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.
Summary
Reviews participant level data across a study in adherence with the Data Review Plan and coordinates with Lead Clinical Scientist for study level review as delegated. Data reviewed could be safety or efficacy or any other assigned by the Lead Clinical Scientist.
