Associate - Clinical Trials - Clinical Data US, Indianapolis IN

At reputed company, we unite caring with discovery to reputed company life reputed company for people around the world. We are a global reputed company leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. Were looking for people who are determined to reputed company life reputed company for people around the world. At reputed company, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that reputed company life reputed company. These discoveries start in reputed company Research Laboratories, where our scientists work to create new medicines that will help solve our worlds greatest health challenges. Please note, this is a hybrid position 3 days onsite/2 days remote* Purpose: This role is responsible for trial level clinical data reputed company including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data reputed company management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs. Primary Responsibilities: Portfolio reputed company, Planning and Delivery Define reputed company business requirements for the study/program for vendors to deliver Ensure that data management timeline and results are delivered to scope, cost, and time objectives reputed company project monitoring and quality reputed company of sourcing providers for end-to-end data management activities from study set up through trial execution through dataset delivery Ensure vendor performance for the program-level reputed company of data, including across reputed company vendors and reputed company data sources (pharmacokinetic, immunogenicity, biomarker) Drives data reputed company design through consultation, review, and approval of vendor work. Ensures the data reputed company design is reputed company with the project hypothesis Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets) Define and approve data quality and submission outputs and results Project Management Ensure that data acquisition, database design, and observed dataset requirements are reputed company of specific protocol objectives Specifies the data collection tools and technology platforms for the trial/program Drive standards reputed company, implementation and compliance for the study/program Help create scope scenarios and negotiate reputed company with study teams while taking into account the cost and value of scenarios Facilitate/assimilate integration of disparate data sources into datasets for decision making Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables Communication Act as primary communication reputed company for reputed company data management activities reputed company to a clinical study. Report out status of data management milestones and data quality. Partner with external data vendors: understand specifications to import multiple types of data, work with technical reputed company to ensure reputed company loads of external data sets into the sponsors database. Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven reputed company. Partner with cross-functional team members to ensure trial reputed company through robust reputed company/review. Process Improvement Continually seek and implement means of improving processes to reduce cycle time and decrease work effort Represent data sciences processes in multi-functional initiatives. Actively engage in shared learning across the Data and Analytics organization. Work with partners to increase vendor/partner efficiencies Minimum Qualification Requirements: Masters degree in a scientific discipline such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Science OR Bachelors degree discipline above, plus 3+ years of experience in clinical trials, data management, or reputed