life sciences setting. Roles & Responsibilities: Proven experience managing enterprise IT environments (servers... dependencies and minimize downtime. Life Sciences & GxP Domain (2–3 years minimum) Exposure to lab systems, manufacturing IT...
that results are reported accurately. Requirements: Bachelor's degree in computer science, Statistics, Mathematics, Life... Sciences or other relevant scientific fields; master's degree preferred. Minimum 6 years of experience in developing software...
in molecular biology, Immunology, or other Biological Sciences. 1-4 years of relevant laboratory experience. Hands-on experience...
.S. or equivalent in computer science, mathematics, or life science. A minimum of 5 years of relevant clinical research programming...
). Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design...
Responsibilities: Review and ensure accurate and high-quality statistical programming deliverables from CRO. Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents. Cr...
Job Description: Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities include. Equipment decommissioning and clean room updates. V...
Job Description: Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities: Equipment decommissioning and clean room updates. Valid...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Job description: We are looking for a highly motivated scientist to join our Exploratory Biologics group in Discovery Research Immunology. The position offers a unique opportunity for a talented scientist to work in a dynamic, innovative, ...
Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirem...
Responsibilities: Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope. Responsible for the accu...
Responsibilities: Providing statistical programming support to generate tables, listings, and figures for assigned projects. Demonstrating proficiency in CDISC, SDTM, and ADaM to support various submission activities, including IA, CSR, ...
Responsibilities: Responsible for the oversight of all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM ...
Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global ...