The posting
Job Summary The Associate Data Manager is responsible for reconciliation tasks of regulated data streams of laboratory data to clients. This role participates in internal discussions and decisions related to the delivery of data services to stakeholders, as well as performs duties associated with day-to-day monitoring of data streams to ensure quality deliverables on time. Essential Duties and Responsibilities
Remediates omissions, inconsistencies and inaccuracies in client data streams. Reviews lab data files to ensure information meets the data transfer specification. Creates test lab data for test data transfer files in accordance with defined processes. Creates lab data transfer specifications for low-complexity studies and communicates with clients’ amendments to the study data structure. Conceives, suggests, and contributes new and improved real-time validity checks in the LabConnect central laboratory information management system. Assists with data transfer specification maintenance as directed by the study Data Manager. Formulates systems and ensures projects meet strategic needs. Initiates and delivers data transfers to clients or their designated data recipient on request or on a schedule agreed with the recipient organization. Ensures the prospective data transmission complies with the data transfer specification document including file structure, format and layout. Ensures consistency of laboratory analyte reference ranges, decimal precision, units of measure and correlation factors where present. Formulates, installs, and verifies laboratory unit conversion tables to standardized versions as defined by data transfer specifications and where applicable. Receives and responds to all client queries relating to their clinical data stream and documents the outcome from the query in the client’s database. Communicates with internal team members to ensure the quality of the data sent to the client and remediates errors consistent with internal processes. Communicates with Investigator Support Services to ensure queries are being resolved. Maintains study schedule in accordance with the contracted agreement and client communications. Performs routine work within the scope and traning as directed by the group manager.
Education and Experience
Associate’s degree or university program certificate in a biologic science concentration preferred. Four to six years of experience in the clinical trial industry strongly preferred. An equivalent combination of above education and experience will be considered. Laboratory experience preferred. Experience in clinical trial protocol development and FDA 21CRF11/GCP strongly preferred. Certification as an ASCP Medical Technologist or Medical Laboratory Technician is preferred.
Skills and Ability
Excellent attention to details. Ability to adhere to established timelines, processes and procedures. Strong planning and problem solving skills. Self-motivating and ability to work well independently, as well as use a collaborative team approach. Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills. Ability to adapt to changing environments and requirements. Excellent listening and verbal comprehension skills, including ability to translate client needs to team members. Ability to make quick but well-thought out decisions. Customer service/client relationship management skills.
Supervisory Responsibilities: None Physical Demands: While performing the duties of this job, the occupant is regularly required to:
Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Use hands and fingers to operate a computer and other office equipment.
Travel Requirements: Minimal One Global Team At LabConnect, we are proud to be one global team: united by our shared mission to advance clinical trials through innovation, agility, and collaboration. We believe that our people are our greatest asset, and we are committed to fostering a workplace that reflects our core values: People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always. LabConnect is an Equal Opportunity Employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), creed, national origin, age, disability, genetic information, veteran status, or any other legally protected status. We are committed to cultivating a workplace that is safe, equitable, and respectful for all. Together, as one global team, we strive to ensure that every individual has the opportunity to thrive and contribute to our shared success. This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job.
