[Hiring] Clinical Data Reviewer @Syneos Health

Role Description

The Clinical Reviewer (CR) is a specialized role that performs clinical review, typically ahead of significant project milestones (interim analysis, study closeout, submission, etc.). The studies supported by the CR are often, but not exclusively, comparative safety and efficacy (Phase 3) trials with large, multi-faceted data sets. The review tasks performed by this role include both point-to-point clinical review checks and interpretive analysis such as reviewing data for submission, highlighting errors, raising queries, etc. from a clinical perspective. The CR will work as an extension of the clinician/clinical scientist and will be responsible for the clinical review of one or more studies with the ability to move easily from project to project as necessary. This requires that the CR be knowledgeable about the therapeutic area under investigation, expected effects of the investigational drug and concomitant medications, and possess sufficient clinical knowledge to assess if data is scientifically and clinically valid.

Job Responsibilities

• Ensure 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 participant level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP).
• Conduct point-to-point data checks (e.g., verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g., reviewing to identify inconsistencies in the participant’s data).
• Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query process.
• Create and use data review best practices and associated data review tools to identify trends and any safety signals.
• May identify protocol deviations during routine clinical review and escalation as appropriate.
• Follow relevant SOPs and regulations, have an excellent understanding of and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
• May liaise with data management, clinical and site management along with other members of the study team.
• Attend Clinical Meetings and Study Meetings as necessary.

Qualifications

• Bachelor’s degree or nursing degree is preferred.
• At least 7 years of clinical research experience in the pharmaceutical industry (Strong monitoring experience is a plus).
• Direct clinical review and query writing/resolution experience required.
• Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
• Prior EDC experience preferred.
• Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)).
• Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis.
• Ability to work independently in a virtual setting and as part of a remote team.
• Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style).
• Possess 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.
• Good written and oral communication skills with strong attention to detail required.

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.