DescriptionPrincipal Clinical Data ScientistSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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 EVERYWHEREWhy 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 our Total Self culture - where you can authentically be yourself.
Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.- We are continuously building the company we all want to work for and our customers want to work with.
Why?
Because when we bring together diversity of thoughts, backgrounds, cultures,and perspectives - we're able to create a place where everyone feels like they belong.JOB RESPONSIBILITIES- Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups.- Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed 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 quality.- Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis.- Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis.- Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables.- Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies.
Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.- Designs and drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results.- Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies.- Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues.- Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics.- Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.- Performs metric collection and data analysis to support continuous process improvement.- Reviews, maintains budget and identifies out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order.- Plans, manages, and requests Clinical Data Science resources for assigned projects.- Coordinates the work of the assigned Clinical Data Science team.- Develops and maintains project plans, specifications, and documentation in line with SOP requirements.- Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files.- Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities.- Prepares input, and participates in proposal bid defense meetings and requests.
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