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Laboratory Information Management Systems Coordinator

2 months ago

Cincinnati, Ohio, United States MyKelly Full time
MyKelly is looking for a Clinical Data Management Specialist with expertise in SAS and LIMS for a dynamic Contract Research Organization (CRO).
Position Title: LIMS Clinical Data Manager
Location: Hybrid
Key Responsibilities:
  • Lead the Laboratory Data Management (LDM) team to ensure timely completion of project objectives while adhering to quality standards and budget constraints.
  • Provide training and mentorship to LDM team members on the implementation and upkeep of studies utilizing Laboratory Information Management System (LIMS) software.
  • Oversee and review new programs developed by the LDM team.
  • Act as the LDM representative on various project teams.
  • Collaborate with Lab Project Managers and Data Management teams to establish study-specific databases at the initiation of new projects and manage any necessary adjustments during the project lifecycle.
  • Conduct quality control checks on databases prior to activation.
  • Facilitate database cleaning processes in partnership with project teams and study sites to ensure a smooth database lock period.
  • Work with clients to formulate data transfer agreements.
  • Plan and manage interim and final data transfers with project sponsors and internal teams.
  • Advise on best practices to enhance the quality and efficiency of deliverables while addressing inquiries related to LDM processes, timelines, and data integrity.
  • Maintain effective communication with internal stakeholders and sponsors, providing regular updates on project progress and collaborating to create coordinated plans that align with client needs.
  • Evaluate team requests by assessing efficiency, quality, budget, resources, and customer relations before taking action; leverage existing knowledge to inform decisions.
  • Develop and maintain comprehensive LDM study files, detailing all internal and sponsor deliverables as per the scope of work, and establish time estimates and data cleaning protocols.
  • Continuously assess timelines against completed work and communicate any impacts on project milestones to laboratory leadership and project teams.
  • Monitor the quality of work performed by the LDM project team and ensure compliance with Global Standard Operating Procedures (GSOPs), providing constructive feedback.
  • Assist the laboratory project manager in managing the LDM project budget by identifying activities outside the contracted scope and obtaining necessary approvals prior to executing out-of-scope tasks.
  • Ensure adequate project-specific training is provided for LDM team members.
  • Generate project reports that fulfill the requirements of sponsors, project teams, and laboratory leadership, ensuring accuracy and timely delivery.
  • Coordinate the receipt and processing of data from external sources, such as contracted laboratories, and perform direct reconciliations where applicable.
  • Prepare for internal and external meetings by completing action items promptly and participating actively in discussions, respecting the opinions of others.
  • Conduct post-project analyses to identify factors influencing project outcomes and provide insights along with study metrics to laboratory leadership.
Qualifications:
  • Bachelor's Degree in Biology, Mathematics, or Statistics.
  • 4-5 years of experience with LIMS.
  • Proficiency in Python, SAS, Oracle, and CDISC.
  • Strong data analysis skills.
  • Experience in a CRO environment.
  • Familiarity with LIMS.
Preferred Qualifications:Experience with Medidata or EDC Management.Knowledge of Quality Control Management.Experience from Start-Up to Close-Out phases.