Participate in clinical meetings with Sponsor and KPS personnel as required. Take necessary actions to ensure data management deliverables are met. Establish rules and procedures for secure and responsible data sharing with executives. Manage data management resourcing for all clinical studies, as required. Prepare documents and ensure tools are arranged to allow for data capture and data cleaning. Ensure delivery of a clean and secure database. Instruct, communicate, coach and mentor others on data management procedures. Ensure compliance with EMEA, FDA, and ICH GCP regulations and policies. Ensure compliance with appropriate Sponsor SOPs. Responsibilities Participate in clinical meetings with Sponsor and KPS personnel as required. Take necessary actions to ensure data management deliverables are met. Establish rules and procedures for secure and responsible data sharing with executives. Manage data management resourcing for all clinical studies, as required. Prepare documents and ensure tools are arranged to allow for data capture and data cleaning. Ensure delivery of a clean and secure database. Instruct, communicate, coach and mentor others on data management procedures. Ensure compliance with EMEA, FDA, and ICH GCP regulations and policies. Ensure compliance with appropriate Sponsor SOPs. Requirements BS/BA or master's degree with preference in a biological, analytical/data, health related, or computer science field. 7-10 years related experience in a pharmaceutical or CRO setting. 5 years' experience in Data Management. Knowledge of EDC solutions (Oracle Clinical, Medidata RAVE, Inform, etc.). Experience working on studies both insourced or outsourced to a CRO. Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite). Strong management and motivation skills. Ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines. Extensive and comprehensive knowledge of international ICH GCP guidelines. Excellent interpersonal, written, and oral communication skills. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
...budding educator looking for opportunities to teach kids and earn extra income? Do you live,... ..., engineering, and robotics? (No coding experience required!) About codeCampus... ...codeCampus is seeking to hire and train Assistant Instructors in the Lynwood area for the...
...Job Description Job Description Description: Job Overview The Underground Utility Drill Operator is responsible for operating directional drill rigs, locating equipment, and product support equipment. This role is crucial in the installation of underground conduits...
...Job Description Job Description Look Great and Feel AMAZING!! V/O Med Spa Rochester is looking for a amazing addition to our team! If you have management experience, a love for beauty and an infectious personality then being a Spa Manager at V/O is the place you...
...About the job Specialist, Data Entry Junior (Remote) CHECK YOUR EMAIL, INCLUDING YOUR SPAM FOLDER, FOR INSTRUCTIONS AFTER APPLYING... ...and an eye for detail? If so, we have the perfect entry-level opportunity for you as a Remote Data Entry Operator at our company...
...comply with UPS appearance guidelines and wear the company-provided uniform \n Full-time casual package delivery drivers work eight to ten hours per day and workdays can vary (Monday - Friday) or (Tuesday - Saturday) depending on the business needs. \n Whats in it...