Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents. Troubleshoot technical issues and design effective data review processes. Manage Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, delegating tasks as needed. Interact effectively with sponsors and oversee vendors. Responsibilities include: Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents. Troubleshoot technical issues and design effective data review processes. Manage Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, delegating tasks as needed. Interact effectively with sponsors and oversee vendors. Mentor junior personnel. Develop SOPs and study-specific procedures. Work with DB programmers to design (e)CRFs and edit checks in EDC systems. Lead User Acceptance Testing (UAT) tasks for complex studies and modules. Coordinate with Sponsor and Vendors for efficient electronic data receipt, integration, and reconciliation. Manage queries and trends to ensure data completeness and integrity. Perform coding of adverse events, medical conditions, and medications. Prepare training materials and user guides for EDC data collection tools. Provide study-specific training for team members and end users. Implement technical solutions and resolve complex issues. Provide regular status updates to cross-functional study teams, management, and sponsors. Ensure archiving of study databases and related documents. Organize and file study documentation. Provide input to cross-functional study timelines and resource requirements. Assist with identification of project scope changes. Present at sales and marketing meetings for prospective clients. Develop SOPs and manuals. Requirements: Minimum BS in a scientific or health-related field or equivalent. Minimum 9+ years of experience in Clinical Data Management. Knowledge of medical terminology and pharmaceutical notation. Expertise with EDC systems such as Medidata Rave, Informa, Medio. Excellent organizational and time management skills. Strong collaboration and leadership skills. We are an equal opportunities employer and welcome applications from all qualified candidates. #J-18808-Ljbffr Katalyst CRO
...Our client is seeking a Security Officer to join their team. As a Security Officer, you will be part of the Corporate Security Department supporting the safety and protection of employees and facilities. The ideal candidate will demonstrate vigilance, reliability, and...
...Studio Details: Description: IA Interior Architects translates client goals, brands, and culture into powerful environments built around people, processes, technologies, and business drivers. Our clients in diverse markets worldwide require high-performance, visually...
Registered Nurse - Emergency Room - Travel - (ER RN)Experience a unique ER nursing adventure in Boston, a city rich in history and vibrant culture. As a registered nurse in the emergency room, you'll help patients in need while immersing yourself in Boston's beautiful...
Job Description Overview Berkot's Super Foods is seeking a Loss Prevention Supervisor. The candidate will be responsible for safeguarding company assets, maintaining a safe shopping environment, and reducing loss related to theft, fraud, operational errors, and safety...
...Step into the Role of Advanced CNC Operator As an Advanced CNC Operator, you're at the center of our production team, bringing precision... ...-quality results. Set up and operate machines to produce parts in accordance with plans and specifications. Ensure machine...