Laboratory Data Specialist

PURPOSE

Be part of a network of individuals who are Clinical Laboratory Data and Reference Range experts, to serve as a resource in consultation and execution of data management strategies with regards to global and local laboratory data needs.

RESPONSIBILITIES

• Serve as a Laboratory Data SME for one or two global clinical trials with fewer than 10 operations staff, or serve in a leadership role to a specific data management task
• Provide leadership to the Operations team regarding laboratory data tasks and information and technology
• May consult with the DM Knowledge and Quality Management Centre for process issues; communicate ideas for process improvement
• May assist in developing and implementing new technology
• Understand and comply with core operating procedures and working instructions
• With minimal guidance, manage Laboratory data project timelines and quality issues, determine resource needs, identify and justify out-of-scope from an operational perspective
• Interact with CDM operational team members to negotiate timelines and responsibilities
• Provide the Data Operations Coordinator (DOC) or Data Team Lead (DTL) with input from an operational perspective for negotiations with the customer
• Perform / manage comprehensive quality control procedures
• Provide data management expertise and data management process improvement to CDM management.
• Mentor other team members in training and developing laboratory data management expertise
• Independently bring solutions to the CDM team
• Develop and maintain good communications and working relationships with the CDM team and project teams
• Meet objectives as assigned

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of the Data Management process (e.g., therapeutic, Laboratory data reconciliation, Central and Local laboratory data, and/or new technology, etc.)
• Previous experience and proven competence in managing delivery of Laboratory data through the study life-cycle (at least on several Phase I studies or 1 Phase II or III study)
• Good understanding of clinical drug development process
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Outstanding communication and organizational skills (detail oriented)
• Ability to exercise excellent attention to detail
• Ability to act independently and with initiative required to resolving problems
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIREMENTS

• A Bachelor’s degree, or educational equivalent, in clinical, biological, or related field, or nursing qualification; with 2 years of related experience including clinical trials experience in a function similar to data management; or equivalent combination of education, training and experience
• A candidate with a Bachelor’s degree in Clinical Laboratory Technology will take preference
• Trained in the Clinical Pathology Laboratory area of expertise, with a solid knowledge of Clinical Laboratory Data, data units and conversion factors
• Have knowledge of the drug development process, and Data Management and Laboratory Data Management’s contribution to the process
• Expertise in the handling of Laboratory Data and Reference Ranges

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