Clinical Data Manager jobs in Henrietta, NY

Full Time 40 hours Grade 052 Neuro-Ctr Human Exp Ther/CTCC

8 AM-5 PM; OCC WKENDS

GENERAL PURPOSE:

The Clinical Data Manager II 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.

RESPONSIBILITIES:

• 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).
• 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.
• Effectively manages assigned projects by adhering to established timelines and deliverables.
• Creates and maintains essential documents for the Trial Master File to ensure compliance to Good Clinical Practice (GCP) standards and applicable regulatory requirements.
• Performs auto and manual coding of study adverse events, medical history, and concomitant medications.
• 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.
• Follows operating procedures and guidelines for clinical data management activities; may lead efforts to identify new procedures and/or tools for clinical data management activities.
• Conducts protocol-specific data management training at Investigator meetings and throughout the course of the study.
• May oversee the activities of junior information analysts.

Other duties as assigned

QUALIFICATIONS:

• Bachelor's degree in health-related, social science or technical discipline and some graduate level course work in that field required.
• One to two years’ experience in research methods and data management is required
• Experience in research methods and data management applied to clinical research is a plus.
• or equivalent combination of education and experience required
• Must be detail oriented, highly organized, and possess good interpersonal and communication skills required.
• Basic familiarity/experience with electronic data capture and/or other data capture and management systems is required.
• Ability to work effectively in teams is required.

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All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled