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
...clinical teams, you'll ensure a seamless customer journey that maximizes the value of our... ...onboarding, training, and continuous success management that align with healthcare workflows and... ...package tied to company growth. Remote-first work environment with flexibility...
...Flexible and Reputable General Contractor in Rochester Job security - strong pipeline of projects into years to come About Our... ...The General Contracting team has successful experience in new construction and renovation of commercial, healthcare, and education...
...health systems in the United States. We're proud to offer many development and advancement opportunities to our nearly 50,000 members of... ...opportunity to directly impact care delivery through education and training. In addition to serving as a clinical educator, the individual...
...committed to loving people with the gospel of the Lord Jesus Christ, located in Greensboro, NC, is looking for a part-time bi-vocational pastor. The candidate should be born again, called to preach and teach God"s Word from a pre-tribulation, pre-millennial evangelical...
About Rockefeller Capital ManagementRockefeller Capital Management was established in 201... ...assets as of December 31, 2024.PositionA Private Advisor team within our Rockefeller... ...individual to join its growing team as a Wealth Management Analyst. The Wealth...