PDS Associate Data Manager

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development.  PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process.  Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.

The Data Manager is responsible for ensuring that any discrepancies with samples received from our customers are appropriately resolved.  This includes interacting very closely with Sample Management Technicians, Project Managers, external laboratories, and clients.   

This role also supports Project Managers by setting up study designs, troubleshooting, and updating studies in the Laboratory Information Management Systems (LIMS).  In addition, this role provides accessioning support when necessary.

This position is an entry-level professional role.  It is paid on a salary basis and is classified as an exempt position.  Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments..  Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated.

The salary range for the role is $43,888 - $65,000 per year.  Salary and job title will be commensurate with experience and qualifications.  Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental, vision,  401K retirement plan and PTO.

Essential Position Responsibilities:

• Acquiring data from primary or secondary data sources and maintaining databases
• Review DTAs to ensure that the correct information will be acquired, and that the data transfer can be obtained through current automated and validated processes.
• Maintain and follow-up on discrepancy case form(s) (DCF)
• Reconcile sample data base as required
• Use clinical data management software to merge data from different sources
• Program exported Watson data files into required format per DTA (prior SAS experience is desirable_
• Participate in client calls
• Assist in accessioning when required.
• Communicate identified process improvement opportunities
• Compile sample shipment manifests to compare with LIMS, presenting findings and action items to relevant team members to ensure that LIMS system data is accurate for study.

Education and Experience Requirements:

• BA/BS in Biological or Physical Sciences and at least 1 year of relevant laboratory
  experience.
• MS in Biological or Physical Sciences may substitute for relevant laboratory experience.
• Must be proficient with MS Office applications, specifically Excel, Word, Outlook, and Teams.
• Prior experience working in a regulated, GLP compliant laboratory environment preferred.
• Prior LIMS experience highly desirable.

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Salary : $43,888 - $65,000