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.
Discover what your 25,000 future colleagues already know:
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
**Open to Canada, US, and UK -- with no sponsorship needs.
**Oncology experience required
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.
Job 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
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:
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.
Get to know 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. Learn more about Syneos Health.
http://www.syneoshealth.com
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. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is 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.
