Responsibilities: The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory departm...
Roles & Responsibilities: Walk through production lines, understand equipment and production processes. Understand the current state information from site leaders and functional managers. Understand current challenges and projects in pl...
Responsibilities: Serve as Clinical Data Management representative in Operational Committee/fora with the partners, DM vendors or other vendors handling data. Participate in working groups e.g. Data protection regulation, setup of data i...
Responsibilities: Maintain study-specific documentation, including Data Management Plans, eCRF specifications, and other related documents. Interact effectively with sponsors and oversee vendors. Develop SOPs and study-specific procedur...
Responsibilities: Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Support database setup activities including edit check specifications and user acceptance testing...