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
...Job Description Job Description The Window and Door Installation Technician will be responsible for installing windows and doors in new construction residential homes. This role requires working outdoors in all weather conditions, using ladders, and operating power...
...This opening is a lead dentist role, Managing Clinical Director. At Aspen Dental, we put You 1st, offering the financial security and job stability that comes with working with a world- class Dental Service Organization (DSO).Our best-in-class learning and...
...Excellence: Drives continuous improvements is open to and uses new technologies and skills and supports others through change At Sam's Club, we offer competitive pay as well as performance-based bonus awards and other great benefits for a happier mind, body, and wallet...
...the position and eligibility. As a Security Officer - Telecom Entry Screener in New Braunfels, TX , you will serve and safeguard... ...: Clear path to full-time roles and ongoing advancement through paid training programs. Smart Tools: Access exclusive technology...
...Physical Therapist Assistants (PTA) for Outpatient Clinics RCM Health Care Services is hiring licensed Physical Therapist Assistants... .... Paid Training Weekly pay W2 and 1099 options Travel packages offered Physical Therapist Assistant Work Hours Full...