Our Ability Jobs

Employer Name: Yale University

1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned. Required Skill/ability 1: Extensive experience working as a Clinical Data Manager and in all facets of study start- up/activation, on-going management of multiple protocols, study close-out, and regulatory submission. Ability to manage and lead a team. Required Skill/ability 2: Experience with EDC, CTMS, and eTMF systems. Knowledge of 21 CFR Part 11 requirements. Required Skill/ability 3: Experience in creating database specifications and building studies in one or more Electronic Data Capture (EDC) systems (e.g. Medidata Rave, Oracle InForm, IBM Clinical Development, Medrio, REDCap, etc.). Required Skill/ability 4: Comprehensive technical knowledge of FDA and EMA clinical data standards and regulations, data management practices (GCDMP), and medical coding (MedDRA, WHODrug). Knowledge of SDTM data standards (CDASH, SDTM, ADaM). Required Skill/ability 5: Experience with project management and computer validation projects. Professionalism, maturity, good judgment, and the ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access. Preferred Education: Master's degree preferred. Project Management Professional (PMP). Certified Clinical Data Manager (CCDM). 10+ years Clinical Data Management experience in industry or CRO. SQL & SAS programming skills (Base, Macro, ODS). Experience with eCTD data submissions, FHIR, data integration from EHR systems (e.g. Epic) and other eSource data sources (Direct Data Capture, eCOA/ePRO). Work Week: Standard (M-F equal number of hours per day) Posting Position Title: Associate Director 4 University Job Title: YCCI Asst. Director, Clinical Data Management Preferred Education, Experience and Skills: Master's degree preferred. Project Management Professional (PMP). Certified Clinical Data Manager (CCDM). 10+ years Clinical Data Management experience in industry or CRO. SQL & SAS programming skills (Base, Macro, ODS). Experience with eCTD data submissions, FHIR, data integration from EHR systems (e.g. Epic) and other eSource data sources (Direct Data Capture, eCOA/ePRO). Bachelor's Degree in related field and eight years of experience or an equivalent combination of education and related experience.