Clinical Data Reviewer (Canada or US) Oncology

1001 Syneos Health, LLC; Alabama; Hybrid; USD 81,000 - 145,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Employee stock purchase plan

Bonus eligibility

Flexible PTO

Job summary

Syneos Health is seeking a Clinical Data Reviewer (Canada or US) to support oncology studies. The role requires 7+ years of clinical research experience, direct data review and query resolution expertise, and strong Excel skills. The candidate must reside in the US or Canada and be able to work remotely within a global team.

The position emphasizes data readiness for milestones, interpretation of complex data, and collaboration with data management and site teams across study phases.

Qualifications

• Bachelor’s degree or nursing degree preferred, with strong clinical background.
• 7+ years of clinical research experience in pharma; strong monitoring is a plus.
• Direct clinical review and query writing/resolution experience required.
• Sufficient clinical knowledge to assess data validity.
• Prior EDC experience preferred.
• Proficient in reviewing large scale listings in Excel and understanding CRF data interactions.
• Ability to work independently in a virtual/remote setting.
• Ability to prioritize and adapt to deadlines in a fluid environment.
• Knowledge of data management and CRF design basics.

Responsibilities

• Ensure data readiness for milestones including interim/final analyses and submissions.
• Review participant-level data per CRF Completion guidelines and DRP.
• Conduct point-to-point data checks and interpretive analyses for data consistency and validity.
• Generate and resolve data queries, escalating when needed.
• Create data review best practices and tools to identify trends and safety signals.
• Identify protocol deviations during routine clinical review and escalate accordingly.
• Follow SOPs and training requirements to improve quality and efficiency.
• Liaise with data management, clinical and site teams; attend clinical meetings.

Skills

Clinical data review

Query writing

EDC systems

Virtual collaboration

Data management basics

Attention to detail

Communication skills

Education

Bachelor’s degree or nursing degree

Tools

Microsoft Excel

Job description

Clinical Data Reviewer (Canada or US)

Oncology 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.

Job Responsibilities

Sr CRA or CTM experience with Oncology is required. Candidates must reside in US 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

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

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.

About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.

We’re a growing, global company dedicated to advancing our talent past their initial role. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it.

We provide 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.

Learn more about Syneos Health. http://www.syneoshealth.com