Clinical Data Reviewer (US and UK Only)

Syneos Health Careers; London; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading biopharmaceutical solutions organization in London seeks a Clinical Data Reviewer to analyze participant-level data and ensure its validity for key regulatory submissions. Ideal candidates will have a Bachelor's degree in life sciences, strong technical review skills, and familiarity with Microsoft Excel and Oracle systems. This remote role accepts candidates from the UK and US, emphasizing detail and the ability to prioritize under deadlines.

Benefits

Career development programs

Supportive and engaged management

Total rewards program

Qualifications

• Thorough understanding of quality data review processes.
• Deep Clinical Research experience in the phase 3 space.
• Moderate tech savviness to learn new systems quickly.

Responsibilities

• Perform clinical data review for multiple studies.
• Ensure patient data validity for regulatory milestones.
• Create best practices for data review.

Skills

Strong technical data review skills

Attention to detail

Ability to prioritize tasks

Education

Bachelor's degree in life sciences or related fields

Advanced degree

Tools

Microsoft Excel

Oracle Clinical Remote Data Capture

InForm EDC

Job description

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 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 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 culture 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. 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 data to find inconsistencies).
• The CDR will create and use data review best practices and associated data review tools to identify trends and 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 is an asset.
• Deep Clinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor, with a track record of successful regulatory submissions.
• Strong technical data review skills and comfort with reviewing large sets of clinical data under challenging timelines.
• Familiar with Oracle Clinical Remote Data Capture and/or other database systems; technically competent with Microsoft Excel and ideally, Access.
• Basic knowledge of data management including case report form design, workings of electronic edit checks, data handling conventions, and interpretation of data status reports.
• Prior InForm EDC experience is a must or a quick learner for data platform technology systems.
• Proficient in reviewing large-scale listings in Microsoft Excel (filter, sort, data format).
• Moderate tech savviness to learn new systems quickly and navigate independently.
• Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis.
• Strong attention to detail.
• Ability to work independently and as part of a team.
• Ability to prioritize and adjust work quickly to meet deadlines.
• 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 FDA-approved drugs, 95% of EMA authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter your role, 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 may assign other tasks at its discretion without prior notice. Equivalent experience, skills, and education will also be considered. This description does not create an employment contract. The company complies with all applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations where appropriate.

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. Data reviewed could be safety, efficacy, or other, as delegated.