Job-ID31519532Reference25-04478 Responsibilities: The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP) Manage database lock activities and contribute to the preparation of clinical study reports (CSRs) Serve as the primary point of contact for data management vendors and oversee their deliverables Participate in study team meetings and provide status updates related to data quality and timelines Support audit readiness and participate in regulatory inspections when required Requirements: Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap) Strong understanding of ICH-GCP, FDA regulations, and CDISC standards Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug) Excellent organizational, analytical, and problem-solving skills Strong communication and collaboration skills across cross-functional teams
A leading online tutoring platform is looking for tutors proficient in German 2. The role offers the flexibility to work whenever you want, providing real-time assistance to students through an AI-powered platform. Tutors earn competitive pay, with options for surge pricing...
...what employers want now. Currently, We are looking for entry-level software programmers, Java Full stack developers, Python/Java... ...to boost their skill portfolio for better job prospects Computer Science grads with limited or no job experience Students...
[Job Title] AP History Teacher [Work Location] Chaoyang District, Beijing, China [School Introduction] This Beijing-based international school follows an American curriculum including AP courses. It focuses on personalised tutoring and holistic education, supporting...
...differential equations. ~9 semester hours in appropriate physical science coursework, including three or more of the following: physical hydrology, statistics, chemistry, physical oceanography, physical climatology, radiative transfer, aeronomy, advanced thermodynamics,...
...Job Title: Starbucks Barista (Part-Time) at Rivers Casino Pittsburgh Position Summary: Join our team at Rivers Casino Pittsburgh as a Starbucks Barista, where you'll play a pivotal role in delivering exceptional customer service. You will be responsible for ensuring...