LIMS Data Management Lead

Functions as Subject matter expert for clinical laboratory data. Responsible for managing biomarker laboratory data for and providing support to internal or external team with respect to data requirements

RESPONSIBILITIES

- Manage delivery of projects through full data management study life cycle.
- Manage project data timelines and quality issues, and identify and justify out-of-scope.
- Respond to Biomarker-related LIMS issues. Works with LIMS Business Lead to address issues.
- Support Biomarker scientists to address issues in content management systems such as: LIMS, EDCMS, etc.
- Perform comprehensive quality control procedures.
- Program the LIMS to handle new biomarker data requests.
- Independently bring project solutions to the Biomarker team.
- Create and/or review data management documents.
- Respond to Biomarker assay data requests and queries
- Produce task-specific training materials.
- Train and support Biomarker team on LIMS usage.
- Ensure service and quality meet agreed upon timelines and deliverables in data transmission agreements
- Ensure quality checks performed on data files before transmission and obtain peer-review where required.
- Ensure that all the needed documentation is filed and stored according to company policy.
- Ensure the internal and external customer queries are timely addressed and resolved effectively.

SKILLS:

- 1-3 years experience with Analytical Techniques required
- 1-3 years experience with Laboratory Information Management Systems (LIMS) required.
- Bachelor's Degree and a minimum of 3 years clinical or research industry or other relevant work experience including 1 -2 years data management experience.
- Strong customer-focus perspective with skill to guide customer communications and customer management.
- Be able to develop and maintain good communications and working relationships within the Biomarker team.
- A working knowledge of Oracle SQL and Visual Basic.
- Self-driven; keen attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change.
- Effective problem solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality.
- Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.
- Good understanding of medical, clinical research, and Lab Data Management process and terminology.
- Knowledge on elicitation of the data requirements and authoring specifications.
- Knowledge on various regulatory requirements such as FDA, ICH, and GLP (Good Laboratory Practices)
- Excellent communication skills
- Excellent planning and organization skills.
- Basic Life Support Certification. Must be CPR certified prior to start.