Clinical Operations Supply and Data Specialist

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Job description

Title: Clinical Operations Supply and Data Specialist
Location: Indianapolis, IN
Duration: 12+ months

Description:
* The Clinical Operations Supply and Data Specialist is a seasoned professional with comprehensive problem solving skills, wide ranging experience, and ability to coordinate other employees' activities. The Clinical Operations Supply and Data Specialist will coordinate and manage aspects of projects and/or phases of larger projects by eliciting and documenting data requirements, as well as coordinating communication within Clinical Operations related to Data and Supply Management under direction of the area leader. This role will collaborate within the team to ensure all Supply Management objectives are met and business goals are achieved. The Clinical Operations Supply and Data Specialist will offer expert guidance to assist with the technical and data aspects of relevant databases and systems utilized within Clinical Operations in support of ongoing process improvement initiatives and routine operations.
* Clinical Operations Supply Management
* As single point of contact and process owner, offer expert guidance in all aspects of clinical trial supply management workload, projects, and processes including but not limited to shipping and receiving, biological sample management, inventory management, collection kit builds, data analysis, process improvement, and project development, as-needed
* As subject matter expert, manage biological sample repository systems, data and samples in collaboration with other Supply Management personnel under guidance from area leader
* Contribute to development of Standard Operating Procedures for Clinical Operations Processes
* Network with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise. Builds and maintains productive relationships with key Roche stakeholders, i.e. CIS, Data Management, Biostats, Traffic/Warehouse, Import/Export, Quality, Calibration and Facilities/Maintenance.
* Exercise judgment in evaluating methods and may determine criteria for obtaining solutions for diverse and often times complex issues
* Follows the principles and applications of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), ISO 13485 and all applicable Regulatory Guidelines.
* Project Management & Process Improvement
* Assist Sr. Supply Coordinator with development of project scope and timelines as a representative of Supply Management on various study teams
* Provide data/systems expertise and Supply Management process knowledge to the project team to create, implement and maintain a full-scale global biological sample management strategy
* Represent Supply Management and Clinical Operations data processes in global cross-functional initiatives
* Evaluate standards decisions, implementation and compliance of new data standards in support of Data Standardization Teams
* Collaborate with both internal and external partner IT service departments to execute system integration and functionality
* Under area supervision, assist with coordination across multiple departments to optimize and improve internal processes for Clinical Operations
* Collaborate with area lead to manage, assess and plan study demand and forecasting
* Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions
* Expert contributor in facilitation of out-sourced activities and projects where applicable
* Lead special projects as assigned by area lead
Laboratory Management
* Ensure lab is in GLP/GCP compliance through coordination of periodic maintenance schedules and internal inspections. Follow all Lab Safety guidelines and wears appropriate PPE.
* Coordinate and communicate all aspects of laboratory and clinical equipment maintenance program including: calibration, exchange schedules and shipping, in a compliant manner. Responsible for maintaining list of calibrated equipment and locations and ensuring equipment is submitted to calibrations department on time
* Business Intelligence & Data Analytics
* Participate in quality assurance and user testing phases of various e-system updates and rollouts
* Subject matter expert for all system applications driving eSystem compliance, supporting end user trouble shooting, establishing processes where needed to drive continuous improvement and efficiency
* Gather data from various sources and databases, as well as utilize advanced analytic tools to create meaningful and industry appropriate analytical dashboards and metrics.
* Maintain best practices with regard to data collection and mining
* As applicable, run daily and weekly reports in Clinical Trial Management System for Inventory Management and delegates tasks and activities for both orders and shipments. Ensures timelines are met. Proactively communicates issues with study team. Ensures records with issues are updated and closed out within timely fashion.
* Contribute to the development of the team's tools, skills, culture and impact for CPS and . Skills
* Strong problem solving and consistent decision making skills
* 5+ years of experience in clinical operations, laboratory, or related function (FDA regulated job experience preferred)
* 3 years of supervisory, team lead, or project leadership experience preferred
* Strong interpersonal skills, proactive, and the ability to work in team environment
* Excellent written and oral communication skills including presentation to groups
* Demonstrated technical skills including computer skills/functional competency in Microsoft Office programs and Google documents
* Roche USA now requires all workers, whether onsite or remote to be fully vaccinated by 11/15/21. Exceptions will be given on a case by case basis only for medical and/or deeply held religious beliefs.
* q Per the CDC 'Fully Vaccinated " means q Two weeks after your second dose in a 2-dose series, such as the Pharmaceutical or Moderna vaccines, or q Two weeks after a single-dose vaccine, such as Pharmaceutical's Janssen vaccine. Requirements:
* Bachelor's degree in relevant field (Life Sciences preferred)
* Roche USA now requires all workers, whether onsite or remote to be fully vaccinated by 11/15/21.
* Exceptions will be given on a case by case basis only for medical and/or deeply held religious beliefs.
* Per the CDC "Fully Vaccinated means: Two weeks after your second dose in a 2-dose series, such as the Pharmaceutical or Moderna vaccines, or Two weeks after a single-dose vaccine, such as Johnson & Johnson's Janssen vaccine #LI-FRESH