Job Description
1. Works closely with subject matter experts and client groups for projects or programs of a medium to large size to consult, conduct analysis, and identify business objectives and solutions. 2. Identifies core customer business issues and provides solution recommendations to address them. Develops necessary tools and workshops to successfully identify issues and evaluate recommendations. 3. Gathers, receives and interprets data, analyses, and reports. Develops reporting modules, ad-hoc reports, and related reporting tools. Conducts research, data gathering, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases. Develops and harnesses the data that is available to identify existing business issues and key drivers and develops solutions and initiatives. 4. Evaluates data gathered from multiple sources in order to support the issues, conclusions and recommendations. 5. Analyzes data with standard methods, interprets the results, and provides written summary and reporting of analysis. 6. Develops and validates queries for the successful extraction of appropriate data. 7. Develops and maintain documentations and libraries on key processes. 8. Ensures accuracy to maintain the high quality and integrity of information, data and databases. 9. Contributes to the development of unit and/or University plans and strategies. Researches, gathers data and provides recommendations. 10. Collaborates with key stakeholders and subject matter experts to establish the vision, analyze costs and benefits and support implementation. Ensures strategic and tactical plans are carried out. 11. Communicates effectively the perspective of business opportunities, needs, and risks. 12. May perform other duties as assigned.
Required Skill/ability 1: Demonstrated experience performing and managing clinical data activities throughout the entire DM lifecycle (start-up, conduct, and close-out).
Required Skill/ability 2: Experience creating and managing studies in REDCap plus at least one other EDC system (e.g., Advarra EDC, Zelta EDC, Medidata Rave, Oracle Clinical, etc).
Required Skill/ability 3: Knowledge of Good Clinical Practice and Good Clinical Data Management Practice guidelines, and federal, state, and local guidelines pertaining to clinical research (including HIPAA, 21 CFR Part 11, and standard operating procedures).
Required Skill/ability 4: Attention to detail and highly organized. Excellent oral and written communication skills and ability to report on the status of projects to manager, principal investigator, funding agency, and collaborators.
Required Skill/ability 5: Flexibility in work focus; ability to switch among different projects without adverse effects to study deliverables/timelines. Ability to work independently, problem-solve and enlist the support of other team members. Strong interpersonal skills to interact effectively/represent the school well with faculty, study team, sponsor, funding agency, and external collaborators.
Preferred Education: Work experience with drug, biologic, or device clinical trials in an academic and/or sponsor/CRO environment. Work experience with investigator-initiated and oncology trials. Knowledge of medical and/or laboratory terminology acquired through education, training, or experience. Work experience with OnCore and Advarra eSource + EDC. Microsoft Excel, Microsoft Project, Microsoft Visio.
Work Week: Standard (M-F equal number of hours per day)
Posting Position Title: Business Analyst 1
University Job Title: YCCI Clinical Data Manager
Preferred Education, Experience and Skills: Work experience with drug, biologic, or device clinical trials in an academic and/or sponsor/CRO environment. Work experience with investigator-initiated and oncology trials. Knowledge of medical and/or laboratory terminology acquired through education, training, or experience. Work experience with OnCore and Advarra eSource + EDC. Microsoft Excel, Microsoft Project, Microsoft Visio.
Bachelor's Degree. Four years of related experience or equivalent combination of education and experience.
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.
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Job Tags
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