Clinical Data Reviewer - Oncology

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.

• 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.

• 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.

• 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.

• 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…