Clinical Data Reviewer (Oncology) Poland or Canada

Clinical Data Reviewer (Oncology) Poland or Canada
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

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 …