LIMS Clinical Data Manager

Kelly Science & Clinical® is seeking a SAS and LIMS Clinical Data Manager for a smaller CRO based out of Cincinnati, Ohio.

Position Title : LIMS Clinical Data Manager

Location : Cincinnati, Ohio Hybrid

What You Will Do :

• Responsible for directing activity of the LDM team members to complete project deliverables on schedule according to quality standards requirements and project budget from project start-up through archival.
• Train and mentor members of the LDM team in the setup and maintenance of studies using laboratory information management system LIMS software
• Provide guidance and review for new programs by the LDM group
• Serve as the LDM representative on project teams
• Work with Lab Project Managers / CRO / Sponsor Data Management in the setup of study-specific database at commencement of new projects, and with any midstream project changes
• Perform database quality control checks before database activations
• Perform or facilitate database cleaning procedures in conjunction with project team and sites over the course of assigned projects to ensure a clean database lock period
• Collaborate with clients to develop data transfer agreements
• Plan and orchestrate interim and end-of-project data transfers with project sponsor and internal teams
• Recommend best practices to improve quality or speed of customer deliverables and respond to questions on LDM process, timelines, and data quality
• Maintain positive working relationship with internal customers and sponsor by keeping them up-to-date about progress of projects and working with them to develop coordinated plans that meet customers needs
• Maintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes and choosing method of communication based on urgency and type of information being communicated
• Evaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action;

seek out existing knowledge prior to developing new methods

Develop and maintain LDM study files; identify all internal and sponsor LDM deliverables contracted in scope of work and establish time estimates;

specify data cleaning guidelines, conventions, Global Standard Operating Procedure GSOP , data workflow, and other processes, which will be followed to meet sponsor requirements

• Continuously evaluate timelines in relation to work completed and communicate impact on milestones to laboratory leadership, project team members, and sponsor
• Monitor quality of work performed by LDM project team and compliance with GSOPs and provide feedback to team
• Support the laboratory project manager in the maintenance of the LDM project budget by identifying LDM activities outside scope of contracted work, obtaining agreement from sponsor or client's management prior to performing out-of-scope tasks, preparing or reviewing budget and cost analysis documentation routinely, and following scope issues through to resolution
• Provide or arrange for adequate project specific training for LDM team members
• Develop project reports which meet needs of sponsors, project team, and client's laboratory leadership, are accurate, and are provided to sponsor and LDM management upon request or a re-arranged schedule
• Coordinate receipt and handling of data received from external sources e.g., contracted laboratories and direct reconciliation where applicable
• Prepare in advance for internal and external meetings, complete action items within required timeframe, and attend internal meetings regularly, providing input, and demonstrating respect for opinions of others
• Conduct post-mortem analysis after study completion to determine positive and negative factors affecting the project and provide information along with study metrics to laboratory leadership

Required :

• Bachelor's Degree in Biology, Mathematics, Statistics
• 4-5 years of experience with LIMS
• Python, SAS, Oracle, CDISC
• Data Analysis
• LIMS

Preferred :

• Medidata or EDC Management
• QC Management
• Start-Up to Close-Out

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.

Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals it's the way we think job searching should be.

Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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