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University of Rochester Senior Clinical Data Manager - 228842 in Rochester, New York

Senior Clinical Data Manager Job ID 228842

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 054 Neuro-Ctr Health & Tech/CTCC

Schedule

8 AM-5 PM; OCC WKEND

Responsibilities

GENERAL PURPOSE:The Senior Clinical Data Manager is responsible for the clinical data management (CDM) activities for the entire life cycle of multiple clinical trials in Phases I-III, from protocol development through database lock. Directs and oversees the activities of staff on study teams. Interacts with Principal Investigators and senior management.

SPECIFIC RESPONSIBILITIES:

Under general guidance and with considerable latitude for the exercise of independent judgment and initiative:

  • Consults with Principal Investigator and Senior Management concerning the studies and projects to be conducted and the best method for securing and presenting information. Evaluates and becomes familiar with research protocols and objectives. Coordinates study start-up activities, including review and sign off of source documents for the electronic data base, source completion guidelines, data validation (edit check) specifications, and the data management plan (DMP). (25%)

  • Devises methods for complex search strategies and collection of information, often using statistical methods and computer programming and analysis. Conducts ongoing data review and cleaning, oversees data entry timeliness and query management with investigative sites to ensure data quality, reconciles serious adverse events and vendor data against clinical database. (20%)

  • Creates and maintains standard operating procedures and guidelines for clinical data management activities; may lead efforts to identify new procedures and/or tools for clinical data management activities. (10%)

  • Effectively manages assigned projects by adhering to established timelines and deliverables. (10%)

  • Ensures proper auto and manual coding of study adverse events, medical history, and concomitant medications. (10%)

  • Oversees locking of the database at study completion and works with lead programmers to ensure databases are well validated and ready for data transfer and/or statistical analyses. (10%)

  • Directs the activities of subordinate staff in the conduct of gathering, compiling and analyzing information. Works with faculty, administrative staff and community groups to establish plans and procedures for the conduct of studies and clarify problems as they arise. (5%)

  • Conducts protocol-specific data management training at Investigator meetings and throughout the course of the study. (5%)

  • Other projects and job duties as assigned. (5%)

    REQUIREMENTS:

  • Bachelor’s degree with major course work in social or technical field, and Master’s degree in Library Science, Information Science or related field desirable, and 4-5 years’ experience in the analysis and dissemination of information plus supervisory experience; or an equivalent combination of education and experience.

  • Knowledge of ICH, GCP Guidelines, and local regulatory authority regulations regarding planning, implementation, coordination, evaluation, and reporting of clinical trials.

  • Competence in electronic data capture systems including eConsenting.

  • Familiarity with risk-based modeling approach and associated software.

  • Strong presentation, interpersonal, and communication skills, including written communication.

  • Strong problem-solving skills, attention to detail, and organizational skills.

  • Demonstrated leadership ability and the ability to manage multiple priorities in a fast-paced environment.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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