Job Description
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 roles provides accessioning support when necessary.
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.
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
- Create studies in Watson LIMS (laboratory information management system) according to study Protocol and data transfer agreement (DTA)
- Ensure Watson the study design allows automated data table generation according to data transfer agreement.
- 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.
- 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)- Assist in training new hires as needed
- Assist in developing standard work flows
- Asist in software validation
- Assist in writing departmental SOPs
Additional Requirements: - Effective written and oral communication skills.
- Sedentary work. Ability to sit at a computer terminal for an extended period.
- Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
- Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
- Regular, predictable attendance during defined scheduled work hours is required.
- Overtime, weekend, and holiday work as required.
- Must have reliable transportation.
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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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