Associate Lab Clinical Data Analyst Job
Position Title: Associate Lab Clinical Data Analyst-1719613
Job Description: An Intermediate level Lab Data Analyst that provides clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (LDM) for the studies awarded to Quintiles laboratory and meets the external client data reporting needs.
- Serve as Data Team Lead (DTL) for a number of regional or global studies or serve in a leadership role to a specific DM Task.
- Manage delivery of projects through full data management study life-cycle (with minimal guidance)
- With guidance from a more senior DTL or Manager, manage project timelines and quality; identify out-of-scope work.
- Serve as back-up for other Data Team Leads (with guidance).
- Perform comprehensive quality control procedures.
- Independently bring project solutions to the LDM team
- Understanding and verification of error logs generated by the QLIMS Data Transmission creation programs and communicate effectively with the programming/support team to resolve if any issues in the Data Transmission.
- Identification of the database set up and programming gaps and Solves issues through using the global issue escalation/communication policy.
- Understand and comply with core standard operating procedures and working instructions
- Meet objectives as assigned
- Develop and maintain good communications and working relationships with LDM team
- Interact with CDM team members to negotiate timelines and responsibilities
- Review own work for accuracy and completeness
- Ensure quality checks performed on data files before transmission and obtain peer-review where required
- Create and/or review of all appropriate data management documents
- Record all evidence of the data transmission process from data file definition to closure of study
- Ensure that all specification and design documentation are filed and stored according to company policy
- Ensure the internal and customer queries are timely addressed and resolved effectively.
- Must be proactive in sharing the knowledge among the team members and conducting
- knowledge sharing sessions in the areas of expertise.
- Use multiple communication styles and skill to effectively broker, audience-specific [peers, senior team members, internal/external customers] business and interpersonal relationships that lead to positive outcomes and successful business results.
- Perform other duties as directed by the functional manager
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Strong customer-focus perspective with the skill to guide customer communications and customer management.
- Self-driven; keen attention to detail to anticipate, address and/or escalate issues, with an aptitude to embrace and be a conduit for change.
- Project and task management capabilities to meet/exceed deliverables.
- Effective problem-solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality.
- Quality conscious with a high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.
- Computer proficiency including word processing, spreadsheet, and PowerPoint applications.
- Good understanding of medical, clinical research, and Lab Data Management process and terminology.
- Knowledge of elicitation of the data requirements and authoring specifications.
- Knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good
- Laboratory Practices) will be an added advantage.
- Qualifications:MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree or educational equivalence in computer/life science or related field with 1 year of relevant work experience; or equivalent combination of education, training, and experience.
- Extensive use of telephone, computer-aided, and face-to-face communication requiring the 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.