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Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
Job Responsibilities
Serves as a Clinical Data Reviewer and identify any errors in data by performing data review per DRP and issuing/closing queries.
Performs ongoing review of clinical/medical aspects of the study participant data and documents (escalates to sponsor Clinical Scientist and/or Study Medical Director, as appropriate)
Examples include but not limited to: Patient eligibility, diagnosis, medical history and prior treatments, study drug administration, AE/SAE/AESI, con meds, IP dose titration and/or compliance, safety labs, efficacy assessments (only if specified), EOT, EOS, survival, coding, etc.
Issues clinical data queries and ensure timely follow up following site responses as to whether the queries are appropriately addressed, and updates in EDC done, if applicable, by either closing out the queries or re-querying, as applicable and with consultation with the clinical team as needed.
Communicates to Sponsor any data training needs or concerns for CRAs, sites, etc.
Provides clinical data review project management status and is viewed as an expert in data clinical/medical review and cleaning.
Ensures data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
Monitors site data entry performance and provide sponsor study team information to assist in identifying root causes of data issues and implementing remedial actions.
Ensures timely follow-up and resolution of clinical data related compliance issues.
Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables.
May contribute to EDC completion training.
May exceptionally participate in clinical data review meetings and/or prepare slides for meetings
May be involved in preparing or review material for and in exceptional cases may present in data dissemination meetings
Will collaborate closely with several sponsor functions mainly Clinical Scientists, Study Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities during study conduct, including prior to data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs and final DBL.
May be involved in QC review of patient narratives.
QUALIFICATION REQUIRED
• Educational scientific background such as MBBS/MD/BDS/BHMS/BAMS/PharmD/PhD
• ≥ 8 years of pharmaceutical clinical/medical data review experience, including clinical crosscheck experience
• Experience in MedDRA/WHO Drug Dictionary coding review
• Excellent Query writing experience
• Strong clinical database navigation skills
• Strong MS excel, powerpoint, experience with clinical data review tools/systems (eg RShiny visualizations, JReview study-specific exception lists, ARGUS, EDC, central imaging, clinical cross-check lists, other clinical data review tools developed to assist in detecting
inconsistent data)
• Strong digital clinical data review analytics tool experience.
• Specific Therapeutic Area/indication experience may be requested
• Excellent verbal and writing communication in English, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Detail oriented
• Proven ability to work independently and strong transparent collaborator in a team setting.
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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.