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, Illuminate, and Veeva TMF will be beneficial. Katalyst Healthcares and Life Sciences
...satellite communications company, based in Alaska. Our company sells and installs direct-to-consumer products including Viasat, Dish, DirecTV and Smart Home products from Google. We are also a distribution partner for OneWeb, a LEO satellite company which will provide...
...Jobseekers who are competing with existing Jobseekers. For entry level Job seekers to get client interviews and jobs they need to... ...looking for entry-level software programmers, Java Full stack developers, Python/Java developers, Data analysts/ Data Scientists, Machine...
...Digital Asset Management (DAM) Manager Remote/White Plains, NY Contract Skills Digital Asset Management, Marketing, Metadata, DAM, DRM, Governance, Copyright, Remote/Hybrid My client who is a leading brand within the CPG industry is currently looking to on...
...Job Type: Full-Time/Part-Time Location: Remote (Work From Home) Job Overview: We are looking for a detail-oriented and organized professional to join our remote team with a focus on customer support. This role involves managing data, handling scheduling...
...growing. small manufacturing company Role Description This is a full-time on-site role located in Dallas, TX for a Finance Manager to be hired exclusively through Firm Placement. The Finance Manager will be responsible for overseeing financial operations,...