LanceSoft – CTSU RPM Specialist One – Ridgefield, CT
Job title: CTSU RPM Specialist One
Company: LanceSoft
Job description: Job Description
Job Title: CTSU RPM Specialist
Duration: 12 months
Location: Ridgefield, CT 06877
- Duties:
- Responsible for Managing and performing tasks along the Clinical Trial Supply Chain for Investigational Medicinal Products (IMPs) within legal and regulatory requirements
- Study specific contact for all final release file preparation, review, modification, and KPI activities, function cost estimates, project time-line system creation / updates, bulk and comparator product order placement and tracking, deviation and CAPA processing, regulatory submission document processing, filing and archiving activities for trial close out, and providing enabling function information to other teams.
- Additional services provided include Product Complaint evaluation, classification, and notification, temperature excursion evaluation and processing
- Experts for multiple computer systems such as Daisy, FoCUS, Idea, eProvisions, SQAM, and BLePs to complete tasks, provide information, and act as key users
- Skills:
- Ability to learn multiple computer systems.
- SAP software based computer systems experience.
- MS Office and MS Teams experience
- SKYPE Meeting or Virtual Meeting software experience
- GMP and Pharmaceutical Industry Regulations knowledge
Education:
Bachelors' Degree or Masters' Degree
Expected salary:
Location: Ridgefield, CT
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