Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. ssist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting. Provide support in setting up infrastructure for external data to flow into Takeda Clinical data pipelines. ssist in validation of all 3rd Party Data generated in clinical trials into Takeda Clinical Data pipelines. Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members. ssist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits. ct as a representative for Takeda in interactions with key external partners as part of the Takeda CT3 3rd Party Data Acquisition team. Support timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF. Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes. ssist in liaising with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of Takeda. Escalate issues to CT3 leadership as appropriate. Requirements: Develop working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles. Gain exposure to all phases of drug development. ssist in handling Clinical data acquisition and management from external/3rd Party vendors. May support study-level negotiation and agreement for data transfer or integration on behalf of Takeda. Collaborate with all levels of employees with moderate supervision required. Familiarity with FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF will be beneficial. Katalyst Healthcares and Life Sciences
...industry. ~ Curiosity and a growth mindset to continuously learn and improve. ~ Capacity to create scalable processes (e.g. demo scripts, POV workflows). #LI-Remote #LI-SL1 PandoLogic. Category:Sales, Keywords:Pre-Sales Engineer, Location:Austin, TX-78703
...Job Description Job Description Criterium Liszkay Engineers is seeking a detail-oriented and dedicated Building and Home Inspector to join our team. In this role, you will play a crucial part in assessing and inspecting various buildings to ensure they meet safety...
...mindset; brew beer, drink beer, and have fun doing it. Since then our brewery has grown but we will always stay the same...Rough morning? Grab... ...or beverage industry preferred Knowledge and a passion for craft beer Able to lift, carry, push/pull cases weighing up to 50...
...Job Summary: The Conservatory of Music at Oberlin College invites applications for the position of Music Theater Sound Designer & Production Coordinator. This is a 12-month continuing, Administrative and Professional Staff appointment beginning on July 1, 2025....
...NEW Regulatory Manager Opportunity-Medical Device! This Jobot Job is hosted by: Audrey Block Are you a fit? Easy Apply now by clicking... ...biologics. We are looking for an AD/Director of Regulatory Affairs! Why join us? Opportunity to wear different hats in a...