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.Job ResponsibilitiesJob SummaryResponsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines.Core ResponsibilitiesServes as Functional Lead for Clinical Data Science including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groupsActs as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data qualityEnsures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysisWorks with assigned project teams to communicate, address, troubleshoot and resolve data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysisCoordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined project analysisDrives the development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assess risks associated with protocol design, study set parameters that could impact the credibility and reliability of the trial results, aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.Drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve data issuesMonitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metricsEnsures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulationsReview, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change orderPlans, manages, and requests Clinical Data Science resources for assigned projectsCoordinates the work of the assigned Clinical Data Science teamDevelops and maintains project plans, specifications, and documentation in line with SOP requirementsMaintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary filesParticipates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilitiesPrepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilitiesPlans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilitiesTrains and mentors new or junior team membersMaintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferencesPerforms other work-related duties as assigned. Minimal travel may be required (up to 25%)QualificationsBA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experienceClinical Data Science experience or an equivalent combination of education and experienceTwelve (12) years of experience in Data management, Data Science including four (4) years of project management experienceExperience in Clinical Data Science practices and relational database management software systemsStrong knowledge of the drug development process and its impact on data quality, in particular risk-based approach, biometrics procedures, workflows.Aptitude for understanding analytic modeling methods such as regression, classification and clusteringStrong project management skills and knowledge of project management methodologiesStrong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferredDemonstrated staff leadership skillsKnowledge of ALCOA++ data quality principlesStrong experience with protocol interpretation, data collection and data cleaning specification developmentExperienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SASKnowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data SciencesProficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applicationsEffective oral and written communication and presentation skillsGood organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detailAbility to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary teamAbility to make effective decisions and manage multiple priorities in a highly dynamic environmentAdditional InformationTasks, 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.
3 months ago