CSL Limited is a leading biotechnology company that provides lifesaving medicines to more than 60 nations. The company and its subsidiaries, which include CSL B
Senior Clinical Scientist
Location
Pennsylvania + 1 moreAll locations: Pennsylvania | Switzerland
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Scientist
CSL Limited
Title: Senior Clinical Scientist Location: Americas, US-PA, King of Prussia, CSL Behring Job Description: Full time job requisition id R-283632 CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Clinical Scientist? The job is in our King of Prussia, PA or Glattbrugg Switzerland office. This is a hybrid position and is onsite three days a week. Reporting to a Global Clinical Scientist Lead, you will support multifunctional, clinical projects in the Cardiovascular-Renal Therapeutic Area. You will work with the Program Director and other Clinical Scientists in performing delegated tasks to support the clinical development program as dictated by therapeutic area/ project needs. The Role - Help develop individual clinical studies according to the clinical development plan within the assigned therapeutic area. - Provide scientific input for the safe and efficient execution of assigned studies, ensuring the highest quality and full compliance of all outputs. - Help develop high-quality program and study level documents and training materials aligned with project plans (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings, clinical study report and regulatory submission documents) in compliance with federal regulations, GCP and good medical practice. regulatory submission documents - Provide clinical science input into design and review of eCRF, SAP, and TLFs. - Support the scientific data analysis and interpretation and help write clinical study reports, internal and external scientific meeting presentations, and publications. - Support the medical monitoring and oversight of individual clinical studies with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, including ongoing review of blinded data, use of data visualization tools and programmed reports. - Identify clinical data trends, issue and resolve corresponding queries, ensure consistency of medical coding and other important data and identification of cases for medical review. Ensure all questions / issues requiring medical oversight are brought to the attention of the Medical monitor. - Manage the processes and partnerships required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, clinical events committee). - Collaborate with internal and external partners to ensure translation of the clinical protocol into operational deliverables, serve as primary contact for protocol guidance, provide training to the clinical execution team. Qualifications: - Bachelor's degree, or equivalent with minimum of 5 years' experience in the biotechnology or pharmaceutical industry (or biomedical research organization) required; OR Advanced degree (Master's, PhD) with relevant clinical focus and minimum 3 years experience - Knowledge in the drug development processes for pharmaceuticals with experience in biotherapeutics desirable (e.g. therapeutic proteins, monoclonal antibodies), and demonstrated ability to use systems and tools (e.g., EDC systems) for data collection, analysis and reporting. - The ability to work collaboratively in a matrix environment is necessary. - Experience working with CROs and AROs, including providing oversight. - Proficient knowledge and technical skills to support study specific data review, trend identification, data interpretation #LI-HYBRID About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process.
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Reporting Clinical Genomics Scientist – HCT
Ambry GeneticsFinding Answers Through Quality Genetic Testing
• Interpreting diagnostic test results • Review and summary of relevant medical literature • Review and summary of clinical information • Apply variant classification guidelines for assay findings • Follow report generation protocols to meet requirements for quality and turnaround time • Attend trainings for the reporting protocols applicable to the specific position or specialty • Become knowledgeable in the information technology systems needed to perform tasks relevant to the specific position • Work towards expertise in clinical and technical aspects relevant to the specific position • Interpret clinical diagnostic testing results in accordance with established SOPs • Variant assessment and classification • Independently draft clear, accurate clinical testing result reports
Senior STARS Improvement, Clinical Professional
HumanaLouisville, Kentucky-based Humana is a leading healthcare company that offers a variety of health, wellness, and insurance products and services designed to off
Role Description Become a part of our caring community as a Senior Stars Improvement, Clinical Professional. This work focuses on areas of clinical emphasis and begins to influence the department’s strategy. Makes decisions on moderately complex to complex issues regarding technical approach for project components, and work is performed without direction. Exercises considerable latitude in determining objectives and approaches to assignments. - Continue to focus efforts and identify opportunities on performance improvement for assigned providers. - Actively engages provider during virtual visits to facilitate education, HEDIS outcomes, care of members, and bi-directional feedback. - Attends JOCs with providers and participates in active discussions on HEDIS, member care, and clinical/quality outcomes. - Communicate clinical quality initiatives to assigned providers. - Educate and assist providers in reducing potential preventable events. - Educate providers and staff about Medicaid Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey. Qualifications - FL RN License - Must reside in the state of Florida - Bachelor's degree in nursing - Experience with Medicare, Medicaid, or dual eligible populations - Prior experience in a fast-paced insurance or health care setting - Understanding of healthcare quality measures STARS, HEDIS, etc. - Experience collaborating with cross-functional teams - Comprehensive knowledge of Microsoft Office Word, Excel, and PowerPoint - Proven analytical skills - Excellent communication skills, both oral and written Requirements - To ensure Home or Hybrid Home/Office employees’ ability to work effectively, the self-provided internet service must meet the following criteria: - At minimum, a download speed of 25 Mbps and an upload speed of 10 Mbps is required; wireless, wired cable, or DSL connection is suggested. - In certain roles, the minimum recommended internet speed required by Humana may not be sufficient for business needs. Humana reserves the right to require associates to upgrade their internet service if necessary. - Work from a dedicated space lacking ongoing interruptions to protect member PHI / HIPAA information. - Occasional travel to Humana's offices for training or meetings may be required. Benefits - Competitive benefits that support whole-person well-being. - Medical, dental, and vision benefits. - 401(k) retirement savings plan. - Time off (including paid time off, company and personal holidays, paid parental and caregiver leave). - Short-term and long-term disability. - Life insurance and many other opportunities. Company Description Humana Inc. (NYSE: HUM) is a leading U.S. healthcare company. Through our Humana insurance services and our CenterWell healthcare services, we make it easier for the millions of people we serve to achieve their best health – delivering the care and service they need, when they need it.
Principal Biostatistician – Team Lead
Cleveland ClinicYour source for health news, tips and information from one of the nation’s top hospitals.
• Serve as the team leader for a collaborative group of biostatisticians, data managers, data entry personnel and programmers • Provide statistical expertise in the design and conduct of clinical trials and research studies • Lead multiple projects or complex components of large-scale studies simultaneously • Oversee statistical programming, database management and data analysis activities • Help shape departmental policies and determine resources and budget needs for statistical support • Coordinate the training and development of statistical personnel • Participate in initiatives that advance the mission of the department
Lead Biostatistician
Cleveland ClinicYour source for health news, tips and information from one of the nation’s top hospitals.
• Work collaboratively with a team of biostatisticians, data managers, data entry personnel and programmers to accomplish research objectives • Lead the establishment and maintenance of computerized databases for internally and externally funded research • Provide statistical expertise to investigators and researchers • Coordinate the training and development of statistical personnel • Track project team progress and adherence to deadlines • Review and provide feedback on the design and conduct of randomized and non-randomized clinical trials or retrospective studies • Develop areas of special interest, pursue independent topics for presentation or publications, and apply innovative statistical analyses to specific research projects for which standard methods of analysis are not appropriate • Consult with investigators on methods and procedures for implementing studies and clinical trials



