Amber Anderson Email & Phone Number

Amber Anderson is a Senior Project Specialist at Premier Research.

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  Senior Project Specialist

  Premier Research

  Jul 2021 - Present - Remote

  • Co-leads, alongside the PM, to ensure overall Project Delivery through coordination and oversight of the cross-functional project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety). • Assists with managing the eTMF development, implementation, and ensures documentation is correctly classified and audit ready.• Oversees project’s study timelines based on day-to-day operations and milestones achieved.• Provides scales management for over 43 raters.• Communicates with all site personnel to effectively collect and track start-up regulatory documentation.• Manages the distribution of study supplies, assessments, and lab materials.• Manages site’s IP ordering.• Oversees the ordering and construction of ISF Regulatory binders.• Assists with IRB submissions and document tracking.• Manages collection of both internal and external system user access requests, training, and accesses.• Collects information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases. • Creates and maintains the required project systems, SOP indices, and study team lists.• Manages study team/contact lists, system access requests, and e-mail distribution lists as required. • Collaborates with the functional leads in the development of team trainings to maintain the study training matrix. • Ensures effective communication by scheduling internal and external team meetings, developing agendas, capturing minutes, and managing the action/decision log.• Applies standard operations procedures and ICH/GCP best practices in all responsibilities assigned.

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  University Of North Carolina Wilmington

  Gpa - 3.58