Clinical Data Reviewer - Oncology Required (US, CAN Only)

Clinical Data Reviewer - Oncology Required (US, CAN Only) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Industry experience with Oncology is required. Candidates must reside in US or Canada with no sponsorship needed. Perform clinical review ahead of significant project milestones such as interim analysis, study closeout, submission, etc. Support comparative safety and efficacy (Phase 3) trials with large, multi-faceted data sets. Conduct point-to-point clinical review checks and interpretive analysis, reviewing data for submission, highlighting errors, raising queries. Work as an extension of the clinician/clinical scientist and be responsible for the clinical review of one or more studies, moving easily from project to project as necessary. 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 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 and interpretive analysis, e.g., identify inconsistencies in the participant’s data. Generate queries on discrepant data, 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. Identify protocol deviations during routine clinical review and escalation as appropriate. Follow relevant SOPs and regulations, comply with applicable training requirements, seeking improvements in quality and efficiency. Liaise with data management, clinical and site management along with other members of the study team. Attend Clinical Meetings and Study Meetings. Qualifications Bachelor’s degree or nursing degree preferred. At least 7 years of clinical research experience in the pharmaceutical industry; strong monitoring experience is a plus. 3+ years of oncology experience. 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 (filter, sort, data format). 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 (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. Benefits The benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), 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. 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. We are 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. We comply with the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. Our goal is to help all candidates find great careers. The information you provide here is secure and confidential. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC