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ICON Clinical Research, LLC seeks a Clinical Data Science Lead in Blue Bell, PA.

Duties:

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance. Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures. Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations. Complete all assigned training (including the Study Lead Development Program) and courses in the ICON Training Management system (iLearn) ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies. Record all billable and non-billable time in the appropriate timesheet management system (e.g. Planview™). Take part in study kick off (internal and external) meeting along with the DMPM. Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study. Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst. Assist in compiling the change order log for review by the DMPM. Develop an understanding of the revenue recognition and revenue forecasting process. Assist the DMPM with revenue recognition and revenue forecasting process on a monthly basis. Lead the development of specifications, implementation, and testing for the eCRF or paper CRF. Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS). Lead development of the data management plan and study specific procedures. Ensure effective implementation of standard metric and status reporting on the study. Lead development of specifications for custom reporting on the study. Perform project-planning tasks and support the DMPM in the development of the project plan and timelines. Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors. Adhere to ICON SOPs, the Data Management Plan and study specific procedures in the implementation of tasks on the study. Adhere to the project plan and timelines in the implementation of study tasks during set-up, maintenance and close-out of the study. Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components. Organize and lead regular data management team meetings, both internal and with the sponsor and the DMPM. Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor and the DMPM. Maintain and track meeting minutes, issues and decisions logs, and escalations. Support the DMPM in negotiation of time lines and decision making on the study. Provide regular study status update to the DMPM. Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is documented and the documentation filed in the Data Management Study files. Assess the training needs of study team members on an ongoing basis. Provide refresher training to team members as required. Provide feedback to the DMPM on issues with study team member performance. Support the DMPM in the delivery of training to cross-functional study team members both. Telecommuting is permitted.

Requires a bachelor's degree in Data Management/Science, Pharmaceutics, or related field (or its equivalent) plus 5 years of experience. Requires at least 4 years of experience with leadership. Requires at least 4 years of experience with functional knowledge ( Clinical Data Management). Requires at least 4 years of experience with Elluminate setup, maintenance and close out expertise. Requir s at least 4 years of experience with profound knowledge in the development of Elluminate for data cleaning, including the vendor data setup. Requires at least 4 years of experience with in-depth working knowledge of Data Central and CTOA modules. Requires at least 4 years of experience with eCOA database setup, eCOA configurations, eCOA device UAT, eCOA portal UAT and maintenance of data throughout the project. Requires at least 4 years of experience with cross functional collaboration with SDTM, Biostatics team, Medical Monitoring, Safety, Coding, Clinical Operations and Statistical Programming teams. Requires at least 4 years of experience with leading the development of Coding listings, External Data Transfer Agreements, Third Party Listings, SAE Listings, Exceptional Listings, ECG Listings, Safety Lab Listings, IRT Listings, Study Management Reports, Clean Patient Tracker and CDM status reports. Requires at least 4 years of experience with Database Design, Specifications, and Development of eCRFs, ensuring adherence to standards throughout the project. Requires at least 4 years of experience with developing new Standards, liaising with the Standards Team to create study specific Standards. Requires at least 4 years of experience with expertise in the database setup of various clinical trials, Phases 1 to 4. Requires at least 4 years of experience with managing competing priorities effectively, handling complex setups and database locks. Requires at least 4 years of experience with mentoring and support the team at SME level. Requires at least 4 years of experience with vast experience in multiple therapeutic areas, Cardio Renal, Cardiovascular, Inflammation, Immunology, Neurosciences. Requires at least 4 years of experience with and is the applicant an expert in Immunology therapeutic area. Requires at least 4 years of experience with expertise in Medidata Rave, Medical Affairs Rave 5.4, iMedidata. Requires at least 4 years of experience with in-depth knowledge of industry standard KPIs, and reporting metrics? Requires at least 4 years of experience with expertise in root cause analysis and Risk Mitigation Strategies. Requires at least 4 years of experience with leading the inspection readiness documentation and actively participation in the audits.

40 hours/week. Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply https://www.jobpostingtoday.com/ Ref #18380.