Clinical Systems Specialist

Clinical Systems Specialist

11 Dec 2024
Pennsylvania, Kingofprussia, 19406 Kingofprussia USA

Clinical Systems Specialist

Responsibilities: Provides management of clinical and operational data within on one or more studies within a designated Therapeutic Area (TA) or is a team member a function that supports the delivery of the portfolio. Functions supporting this activity includes Data Management, eClinical Operations, R&D Business Support, as well as Performance Management Executes the overall clinical and operational data for their study. Supports the entire data flow of studies to enable delivery of high-quality, consistent and integrated datasets for regulatory submissions. Where required, supports the broader R&D data strategy through systems and processes Manages a system within the overall eClinical Technology suite of systems for the Therapeutic areas. For the system, translates business needs into the eClinical Roadmap. Implements, maintains and supports eClinical solutions. Configures and integrates eClinical solutions on project and study level. Applies Business Intelligence reporting to enable data driven decisions Ensures all activities that support the TA model are successfully planned, implemented and completed in accordance with the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget Follows the processes, systems and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standardsQualifications: Bachelor degree, or equivalent, in Science related discipline; Post graduate qualifications in scientific or business related field preferable 5+ years experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment Proven leadership and global Clinical Operations experience is essentialDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring (https://www.cslbehring.com/our-company) .We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.Do work that matters at CSL Behring!R-248104CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement

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