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 Clinical 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 roles provides accessioning support when necessary.

Qualifications:

BA/BS in Biological or physical Sciences and at least 3 - 5 years of relevant laboratory experience, MS in relevant field and at least 1-2 years of relevant laboratory experience.

Essential Position Responsibilities:

• Developing and implementing data analyses, data collection systems and other strategies that optimize statistical efficiency and quality
• Acquiring data from primary or secondary data sources and maintaining databases
• Identify, analyze, and interpret trends or patterns in complex data sets
• Filter and “clean” data by reviewing Work with management to prioritize business and information needs
• Locate, communicate and define new process improvement opportunities
• Adept at queries and presenting findings

Additional Responsibilities: (if applicable)

• Create data tables, maintain data release database
• Answer client questions
• Assist in training new hires as needed

Additional Requirements:

• Overtime, weekend and holiday work as required.
• Effective written and oral communication skills.
• Work requires passing pulmonary function test, annual physical and the use of other PPE (personal protective equipment)
• Work requires some standing and sitting for long periods of time, including working within a laboratory hood and at standing bench top.
• Intricate work with hands.
• Must have reliable transportation

Professional Responsibilities: (if applicable)

• Attend continuing education courses, as appropriate.

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