Lab Clinical Data Analyst
Responsible for high-level problem solving of Lab Clinical Data issues as raised by the Lab Data Management Team or client data managers. Able to commission tool creation supporting data integration across multiple databases, including data verification. Familiarity on the Lab Information Management System and proficiency in electronic Data Transfer Process. Uses multiple approaches or technologies to solve a problem within established standards and procedures. Understand and comply with core standard operating procedures and working instructions.
- Provide expert review and guidance for production of Data Management deliverables, database design and set-up, validation definition and programming, and database deliverables to internal and external customers.
- Ensure service and quality, meet agreed upon timelines and deliverables in data transmission agreements for the projects and or staff that are being supported.
- Identify database set up and programming gaps and solve issues through technical expertise and develop lessons learned.
- Ensure that appropriate data management documents are created, review and/or sign-off by the staff being supported.
- Attend customer meetings and lead discussions of project requirements and strategic planning.
- May serve as a Data Management Customer Liaison for one or more customers and Project Management teams.
- Serve as the escalation point for unresolved data issues, identifies root cause(s) and work with client data managers and internal team members for short and long-term resolutions. May serve as a Laboratory Data Analyst for a number of global studies and serve in a leadership role.
- Interact with internal and external team members to understand escalated data issues in order to arrive at the optimal resolution on a short and long term basis.
- Perform dataset quality review and ensure the internal and external customer queries are addressed and resolved effectively, including follow-up and resolution of compliance issues.
- Provide operational input into proposals and scope of work. Participate in proposal defenses. Provide input to costing, particularly at the protocol level.
- Track service performance and provide leadership to identify root causes of issues.
- Train and mentor appropriate support staff for various clinical trial and Companion Diagnostic projects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Advanced knowledge of Data Management processes and systems
- Strong technical programming skills
- Strong project and task management capabilities and ability to manage multiple projects and tasks simultaneously
- Strong 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
- Excellent understanding of medical, clinical research, and Lab Data Management process and terminology
- Strong knowledge of various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree or educational equivalence in computer, life sciences or a related field, or a related field with 7 year of relevant work experience including programming experience or combination of computing qualification and professional experience; or equivalent combination of education, training and experience.
- Familiarity in Visual Basic and SAS strongly preferred.
- Familiarity in SQL (various types) and database technologies.
- Extensive use of telephone, computer aided, and face-to-face communication requiring accurate perception of speech and clear articulation and idea formation.
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time.
EEO Minorities/Females/Protected Veterans/Disabled
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