Description Clinical Data Reviewer - Oncology
**Industry experience with Oncology is required
**Candidates must reside in US, UK, or Canada with no sponsorship needs.
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.
ROLE 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 Me
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 meetings, as necessary
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$80,600.00 - $145,000.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
