Position Summary
The Clinical Data Manager (CDM) I is responsible for providing data management support services for assigned projects. This role is responsible for ensuring that Clinical Data Management best practices, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Work Instructions (WI) are followed to support project deliverables, processes, and standards.
Responsibilities and Duties
- Performs all aspects of the data cleaning process in accordance with study specific guidelines and work instructions.
- Responsible for discrepancy management, data listing/report creation and review, and vendor reconciliation.
- Assists the Lead Clinical Data Manager with the development and maintenance of data management study documentation (e.g., Data Management Plan, CRF completion guidelines, Data Transfer Agreement), including trial master file uploads.
- Compiles, analyzes, cleans, and validates clinical trial data in preparation for project milestones and deliverables.
- Generates data management metrics reports and monitors progress to ensure timelines are met.
- Supports the creation and implementation of clinical database systems, data collection tools and applications through user acceptance testing, user account management, and maintenance activities through database archival.
- Designs and programs outputs to be able to identify, analyze and interpret trends and patterns in complex data sets.
- Communicates and collaborates effectively with internal operations team and vendors to ensure accurate and complete data collection.
- Conducts assigned project work under close supervision with little latitude for independent judgement.
- Other duties as assigned.
Your profile
- Minimum of Bachelor’s degree in Health Sciences, Life Sciences, Mathematics, Computer Sciences, or a related discipline (or international equivalent) preferred. Prior data management work experience may be considered in absence of degree.
- 0-1 years relevant experience in a CRO, Pharmaceutical or Medical Device Company for entry level Clinical Data Manager.
- Exposure to statistical programming packages (e.g., R, S, SAS, SPSS)
- Effective written and verbal communication
- Well organized and detail oriented
- Ability to handle multiple projects and prioritize effectively