- Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories: Data Review
- Performs data review of clinical trial data, including query management
- Performs reconciliation review of external data against EDC data
- May assist in creating study documents or assist in running study reports and metrics
- Performs additional review activities for interim and final database locks as needed. Documentation & Filing
- Files study documentation in electronic Trial Master File (eTMF) and department project files.
- Performs periodic quality review of eTMF documents.
- Assists with taking meeting minutes and documenting/tracking study data management activities.
- Performs data archival activities.
- Performs inspection readiness activities and supports CDM team during internal and regulatory inspections Data Collection Systems May support the set-up and testing of study data collection tools. Additional Activities
- Assists with quality review of above activities performed by the CRO, as needed.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Performs other duties as assigned. Educational Qualifications
- Associate or bachelor's Degree preferred Experience
- Ideally 6 or more years relevant work experience, or equivalent combination of training and experience.
- Familiar with electronic data collection systems
- Preferred knowledge of data management best practices & technologies as applied to clinical trials.
- Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Special Skills/Abilities • Strong attention to detail, and organizational skills
- Positive time management skills
- Quick learner and comfortable learning new technologies and systems
- Good knowledge of office software (Microsoft Office). Behavioral Competencies
- Is comfortable with ambiguity.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Job Complexity
- Low-Medium complexity project.
- Occasional domestic/international travel to other sites, strategic partners, and therapeutic area events may be required.