Description #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. 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.
Clinical Data Reviewer
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
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.
What we're looking for
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 assetDeep Clinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor and with a track record of successful regulatory submissionsStrong background in OncologyStrong 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 systemsProficient 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 systemsBasic understanding of how data points from different field/CRFs interact and how data collection impacts analysisStrong attention to detailAbility to work independently and as part of teamAbility 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 listingsReview tracking required (Excel format)
Able to work on the computer, communicate efficiently via phone and/or WebEx.
Mentally able to fulfill the responsibilities of the role.
Must have the relevant personality features supporting the responsibilities:
In addition to the required technical knowledge and experience, a CDR must possess a willingness to perform primarily data review tasks. Able to work independently for periods of several days with minimal supervisory contact.Willing to work in a virtual team setting where there is very little in-person contact.Leverages knowledge from others related to overall objectives, strategy, critical issues and policy mattersHas foresight and judgment in complex decisionsLeverages a variety of communication tools and techniques to communicate resultsPromotes innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processesAbility to work proactively and independently, organize tasks, time and priorities of self and others; ability to multi-taskCollaborative problem solving (handles conflict constructively)Able to embody leadership behaviors and competencies
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
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.