Lab Data Analyst

Job Overview

We are looking for a clinical laboratory data expert to assist in developing and managing Laboratory Data Management (LDM) activities for projects assigned to Q squared solutions, ensuring fulfillment of external client data reporting requirements. This role may involve supporting new system and process development for electronic data transfers and configuration of business rules and master data in laboratory and study information systems. Compliance with standard operating procedures and work instructions is essential.

Key Responsibilities

• Independently handle or contribute to Python programming tasks to support study and department projects.
• Develop and review all relevant data management documentation.
• Adhere to core standard operating procedures and instructions.
• Maintain effective communication and collaboration within the LDM team; provide backup for other Data Team Leads.
• Coordinate with internal and external stakeholders regarding schedules and responsibilities.
• Train and mentor junior data management staff.
• Ensure data transmission agreements are met with timely service and quality checks, conducting peer reviews as needed.
• Keep detailed records of data transmission processes from file definition to study closure.
• Manage filing and storage of specification and design documentation according to company policies.
• Address internal and external customer queries promptly and effectively.
• Utilize various communication styles to foster positive business relationships with peers, senior staff, and clients.
• Assume additional responsibilities as directed by functional management.
• Specific to Local/External Laboratory roles, act as the primary local lab liaison for global studies to clients, CRAs, and site monitors.
• Provide scientific and technical consultation to laboratory staff to resolve data-related inquiries.
• Produce formal documentation complying with operational procedures for managing local lab data.
• Oversee projects throughout the data management life-cycle, from initiation to study lock.
• Support identification and resolution of service issues and develop contingency plans to mitigate laboratory risks.
• Collaborate with customers, scientific teams, and internal members to manage escalations and workload balancing.
• Communicate with customers to meet deadlines and ensure data delivery complies with company and regulatory standards.
• Manage project timelines and quality control with supervision; identify out-of-scope client requests.
• Assist with data entry, validation, and review of laboratory reports; serve as a back-up contact.
• Perform thorough quality control and edit checks on data.
• Support service delivery by applying comprehensive process and technical knowledge, implementing corrective and preventive actions.

Qualifications

• Bachelor's degree: For Local/External Lab roles, a Medical Technologist or Clinical Laboratory Scientist degree with clinical lab experience is required. Alternatively, a Computer Science degree with software configuration and validation background is suitable.
• 2-3 years experience in Data Management and SAS programming, with foundational knowledge of SAS and data management procedures acquired through previous roles or education.
• Additional 2 years related experience in a clinical laboratory for Local/External Lab roles.
• Strong customer service orientation and communication skills to effectively manage client interactions.
• Detail-oriented with the ability to anticipate, address, or escalate issues; adaptable to change and a driver for process improvements.
• Competent in managing multiple projects and tasks simultaneously with sound problem-solving capabilities.
• High ethical standards and strict adherence to laws, regulatory standards, and company policies.
• Proficient in Microsoft Windows and Office applications at user level.
• Good knowledge of medical, clinical research, lab data management terminology and processes.
• Familiarity with applicable regulatory requirements such as FDA, ICH, ISO HL7, and Good Laboratory Practices (GLP).

Additional Information

This position requires dedication to integrity throughout the hiring process and employment. Misrepresentation or falsification of information may result in immediate disqualification or employment termination per applicable laws.