About the role
Clinical Data Reviewer (Oncology) Poland or CanadaSyneos 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
CRA or CTM experience with Oncology is required
**Candidates must reside in Poland or Canada with no sponsorship needs.
TheClinicalReviewer(CR) is a specialized role that performsclinicalreview, 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-faceteddatasets. The review tasks performed by this role include both point-to-pointclinicalreview checks and interpretive analysis such as reviewingdatafor submission, highlighting errors, raising queries etc. from aclinicalperspective. The CR will work as an extension of the clinician/clinicalscientist and will be responsible for theclinicalreview 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 sufficientclinicalknowledge to assess ifdatais scientifically andclinically valid.
ROLE RESPONSIBILITIES
Ensuredatareadiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions,DataMonitoring Committee reviews and publications
Review participant leveldataacross a study in adherence with CRF Completion guidelines (CCGs) and theDataReview Plan (DRP)
Conduct point-to-pointdatachecks (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’sdata).
Generate queries on discrepantdataand follow to resolution including escalation of issues that cannot be resolved through the query process
Create and usedatareview best practices and associateddatareview tools to identify trends and any safety signals
May identify protocol deviations during routineclinicalreview 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 ofclinicalprocedures
May liaise withdatamanagement,clinicaland site management along with other members of the study team
AttendClinicalMeetings and Study Me
QUALIFICATIONS
Bachelor’s degree or nursing degree is preferred
At least 7 years ofclinicalresearch experience in the pharmaceutical industry (Strong monitoring experience is a plus)
Directclinicalreview and query writing/resolution experience required
Possess sufficientclinicalknowledge to assess if participantdatais scientifically andclinically valid.
Prior EDC experience preferred
Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort,dataformat (date).
Basic understanding of howdatapoints from different fields/CRFs interact and howdatacollection 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 ofdatamanagement including case report form design, workings of electronic edit checks, implementation ofdatahandling conventions and interpretation ofdatastatus reports
Good written and oral communication skills with strong attention to detail required meetings, as necessary
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.
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.
Originally posted on Himalayas