Clinical Data Analyst, Clinical Data Management
San Diego, CA
- We are seeking a responsible, dynamic, creative and highly motivated Clinical Data Analyst to join our Clinical Data Management (CDM) team to help with the creation and maintenance of clinical databases.
- This opportunity involves collaborating with others to effectively and efficiently perform data oversight activities.
- This position is expected to proactively identify and undertake data-related problems and propose solutions.
- This is a full-time position in the company’s San Diego headquarters.
- Performing all aspects of the data cleaning process, with a high degree of accuracy and in accordance with Good Clinical Practices and Standard Operating Procedures, that include but are not limited to data listing reviews and third-party vendor data reconciliation
- Supporting the Project lead where necessary with database testing and development, vendor/data management, and internal document creation and maintenance
- Working in tandem with the CDM team to develop a standardization of design, documentation, testing, and implementation of clinical data collection (i.e., CRF standards), and clinical database review
- Providing input and review of Data Management Plans, eCRF Completion Guidelines, and Manual Review Listing Plans
- Query management from functional group listing and data reviews followed by oversight of proper site update and/or response and appropriate application of internal query guidelines
- Assisting with organizing data reviews and issue management from internal, cross-functional and central monitoring reviews
- College degree(s) in Life Sciences, Computer Science or Business preferred
- 2-3 years of relevant clinical experience in a Pharmaceutical, Biotech or CRO environment preferred
- GCP and regulatory knowledge including FDA and ICH regulations
- A flexible attitude with respect to work assignments and continued industry related education
- Efficiently organizes workload of several simultaneous studies to ensure critical milestones are met, while also maintaining an expectation of quality work
- Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
- Ability to handle even difficult situations professionally and maintain a professional and caring demeanor
- Proven ability to collaborate in a team environment and work independently
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
Please submit your resume or additional inquiries to email@example.com