CLINICAL OPERATIONS tamsen

PERSONAL PROFILE

  • Clinical Operations Manager with a strong background in psychology, specializing in
    neuroscience-focused operations in clinical trials.

EXPERTISE

Clinical Trials Oversight / Operations; Protocols; Clinical Development Plans; Budgets; Operations Documents; Site Monitoring / Auditing; Consultant / Vendor Selection, Contracts, and Oversight; Risk Assessment; Project Management; Medical / Scientific Article Writing; Programming Statistics; Regulatory / FDA Reporting and Quality Control; eTMFs; Documentation QC (GCP); Tracking; Clinical / Patient Data Analysis; Clinical Supply Manufacturing and Labeling; Investigator’s Meetings; Board Presentations and Posters; and Team-building. MA in Psychology – Pepperdine University; BS in Psychology (specializing in behavioral / clinical applications) – California Lutheran University.

PROFESSIONAL EXPERIENCE

Clinical Operations Manager, Ethismos Research, Inc.
Deliver clinical / operational oversight of Phase 2 smoking cessation and opioid-sparing chronic pain clinical trial programs.

Clinical Operations Manager, Neurovance, Inc.
Assisted in writing of operational protocols, clinical development plans, budgets, and operations documents. Monitored and audited clinical sites. Performed vendor and consultant selection, contract negotiations, oversight, risk assessment and planning monitors, project management, medical writing, programming, statistics, and regulatory reporting. Maintained multiple eTMFs for three different clinical trials, including organization of documentation and quality control under GCP. Devised processes for tracking primary end points, finance, timelines, and training. Analyzed clinical data from sites, and oversaw clinical supply manufacturing and labeling. Developed data reporting for investors, as well as board and poster presentations.

Clinical Trials Associate, Neurovance, Inc.
Supported the start-up and maintenance of two clinical trials. Analyzed patient data from clinical sites. Presented findings during clinical investigator’s meeting that included ADHD KOLs. Provided quality control for critical documents for the FDA.

Behavioral Interventionist, Addison Behavioral Resources (ABR)

Provided behavioral therapy to children with Autism Spectrum Disorder. Partnered with Master’s and Doctorate level child psychologists to deliver empirically-based, in-home therapy to clients, focusing on reduction of challenging behaviors (hitting, biting, spitting, tantrums, etc.). Introduced and supported the maintenance of social skills.

 

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