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

Syneos Health • USA-AL-Remote, OH

2d • Remote

About The Position

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team acts with a drug development mindset, applying expertise to understand customer needs and shape solutions. This role is part of a Functional Service Provider partnership or a Full-Service environment, collaborating with problem solvers to achieve customer goals. The company is agile and driven to deliver for its employees, customers, and patients. Syneos Health is committed to developing its people through career development, supportive management, training, and recognition. They foster an inclusive culture where employees can be authentic, driven by a purpose to shape solutions that impact lives. They are continuously building a company that employees want to work for and customers want to work with, believing that diverse colleagues can shape the future of healthcare and accelerate patient progress.

Requirements

• Industry experience with Oncology is required
• Candidates must reside in US, UK, or Canada with no sponsorship needs.
• Bachelor’s degree or nursing degree is preferred
• At least 7 years of clinical research experience in the pharmaceutical industry
• 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

Nice To Haves

• Strong monitoring experience is a plus

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

Benefits

• 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
• flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree