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Project Manager I EDS
| Company | Icon |
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| Location | Utica, NY, USA |
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| Salary | $68616 – $85770 |
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| Type | Full-Time |
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| Degrees | |
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| Experience Level | Mid Level |
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Requirements
- A suggested minimum of 3 years’ experience in a laboratory or project management role, at discretion of hiring manager.
Responsibilities
- Monitor and evaluate bioanalytical projects progress with respect to milestones, budgets and timelines.
- Manage bioanalytical studies to ensure that bioanalysis is well coordinated with in life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period.
- Work with laboratory management to ensure that appropriate resources are available to complete the study to timeline.
- Obtain all client specific documents required for the analysis; i.e., study protocol, randomization lists, COA, demographics, etc.
- Review protocol and amendments to assure adherence to specifications and regulatory requirements.
- Prepare analysis plans suitable to the client’s needs, as specified by contract, and obtain client approval of these.
- Work with laboratory operations to ensure compliance to study and validation plans.
- Provide Sponsors with regular updates, forecasting and communicating study progress. Timely reporting of any significant deviations.
- Ensure that project delivery, reporting specifics, and timelines as agreed are met. Inform laboratory operations, DM and QC/QA of deadlines.
- Maintain records of work conducted in a timely and consistent manner, sufficient to allow real-time tracking of deliverables, including tracking of revenue and resources associated with assigned studies.
- Identify changes to scope of work as defined by contract and ensure that change orders are processed prior to work being executed.
- Review and approve all data in accordance with direction documents and ensure results are documented accurately, completely and compliant with GxP regulations and SOPs. Initiate investigations and event deviations as necessary.
- Proactively identify possible/potential implications of unusual results, work with laboratory staff to investigate and report findings.
- Prepare reports of the work conducted, address all QA findings and provide QA draft report in line with the terms and conditions stated in the signed contract.
- Ensure that all documentation is appropriately archived on completion of the study.
- Review and approve laboratory notebooks and other analytical data as required.
- Maintain awareness of and adherence to all current SOPs.
- Work in compliance with GLP/GCP.
- Any other duties related to maintaining the provision of the Laboratory Analytical Services.
Preferred Qualifications
No preferred qualifications provided.
