A BioSpecimen Data Specialist II position will facilitate the daily operation associated with the management of data within the Biospecimen Management (BSM) function. Biological materials serve as the foundation for research, development and validation of medical products. Availability of specimens is a critical and often a “rate limiting” step in research, development, launch, and support of products. Careful management of the planning, procurement, inventory and distribution process is critical.The BioSpecimen Management function supports the acquisition, characterization, and management of biological materials and associated data, and build of select panels fit for purpose of company’s research and development activities. Education & Experience:• Bachelor’s degree in Biological Science or related field, or equivalent combination of education and work experience. • 2-6 years of related experience required.• Work experience in management of clinical study data in the diagnostics, pharmaceutical or medical device industry.• Ability to handle data meticulously, in a well-organized manner, with understanding of Good Documentation Practices a must.• Basic understanding of Good Clinical Data Management Practices. • Working knowledge of relational database structures, regulatory requirements, project/program management, preferably related to clinical data management a plus. Personal Characteristics & Cultural Fit• Good organizational skills are essential. • Flexibility with respect to projects, unique data handling requirements, and meeting client/organizational goals and expectations.• Good written and verbal communication skills.• Ability to work in a fast paced and dynamic environment with efficiency; and capable of handling multiple projects.• Truly passionate about the importance of data management, as well as the ability to work in a global, matrix environment.• Good cross-functional participation skills.• Ability to build peer networks and manage relationships with client and supplier base • Results and goals oriented.Specific Responsibilities• Under general supervision, the candidate will organize and conduct data management activities, such as, data file transfers from biological materials sources and suppliers, organization of source data files, data review, data quality and consistency checks, resolution of data discrepancies, data import, and data export while working within a validated laboratory information management system, utilizing established procedures, and technical and theoretical understanding.• Supports implementation of sample collection studies and reporting requirements in the validated system.• Assists with computer system validation activities (testing, training, etc.), change management and data standardization, as required, in compliance with business and regulatory standards.• The candidate assumes responsibility for the accuracy, quality, and timeliness of all assigned projects and related activities, and keeps supervisor informed of project status, particularly of significant findings and results in critical problem areas. • Establishes as appropriate internal/cross-functional/customer relationships.• Performs work according to established guidelines and procedures, and as specified by appropriate external regulatory agencies. • Assumes accountability for electronic records management and use of validated systems ensuring information is maintained in a timely manner, accurately and consistently, and according to established formats.• With guidance, analyzes and brainstorms alternative approaches to solve complex problems or develop new perspectives on existing solutions. • Works independently and manages own work flow to accomplish assigned objectives.• Keeps informed of trends and developments in area of responsibility.• May act as a lead for assigned projects or team.
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