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Cogniciti Resume Example

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COGNICITI
Professional Summary

Innovative and results-focused clinical project manager with 15+ years of healthcare experience, and a demonstrated ability to lead project teams through complex change efforts. Professional history emphasizes the importance of effective people management skills, effective communication, and quality data. Even-tempered and persuasive nature allows to easily negotiate.

Skills
  • Knowledge of GCP, ICH, HIPAA
  • Regulatory Compliance
  • Data Verification
  • High-Impact presentations
  • Project Management
  • Theory & Management of Clinical Trial Monitoring
  • Advanced Medical Terminology
  • 7+ yrs direct report management
Therapeutic Experience
  • Phase I-IV experience: Alzheimer's, Parkinson's, Multiple Sclerosis, Ataxia, Migraines, Fibromyalgia, PTSD, Neurogenic Orthostatic Hypotension, Diabetes, Osteoarthritis, Anemia, and others. Operational management experience of First In Human trials (including Bridging Trials)
  • Maintained knowledge through familiarity with clinical and scientific literature, and participation in professional activities
Industry-Specific Work History
Manager, Retention Optimization & Quality, 01/2019 to 10/2019
Cogniciti – Remote, CA
  • Promoted from Research Engagement Expert, April 2019 - gaining autonomy over 8 direct reports. Hired, trained, disciplined, and evaluated performance of Alzheimer's/MCI research engagement staff
  • Oversaw/managed clinical project development to ensure data quality, integrity
  • Set and conveyed recruitment goals to downstream staff, while providing regular coaching to remote team of Research Engagement Coordinators across multiple time zones (coast-to-coast US, Europe, and Canada)
  • Surpassed forecasted KPIs and achieved all-time high randomization and enrollment retention rates by increasing quality of subject pre-screening efforts, maintaining relations with Research sites, while acting as liaison between referrals and clinical staff
  • Maximized team knowledge and productivity by effectively providing protocol training, and education related to target indication (Alzheimer's Disease etiology and pathology) to ensure high quality of referred subjects
  • Regularly monitored key performance indicators, identified potential roadblocks for quality data as well as possible solutions, and identified areas of operational improvement
  • Developed training materials, and designed learning solutions that leveraged appropriate modes of delivery, while monitoring training through various evaluative methods to identify opportunities for improvement
  • Trained team on proper conduct of Brain Health Workshops, and post-workshop engagement of qualified research referrals
  • Built and maintained strong relationships with external contacts (pharmaceutical sponsors, private and academic clinical trial sites) to ensure that research subject referrals were being handled responsibly
Early Phase Project Manager, 10/2018 to 01/2019
CNS Network – Long Beach, CA
  • Promoted from Subject Recruitment Manager, acted as primary contact between site and pharmaceutical company representatives in order to conduct all aspects of successful Phase 1 clinical trials
  • Management of operational aspects of Phase II-IV clinical trials from study start-up, while adhering to protocol, GCP, SOPs
  • Assessed trial feasibility (recruitment capability, timelines, vendor access, equipment availability, staffing requirements), ensuring deliverables met or exceeded standards
  • Reviewed proposals/budgets, and proactively identified potential study issues/risks, while implementing solutions
  • Maintained high-level timelines with input from functional departments/vendors, across multiple time zones
  • Managed/facilitated weekly business development meetings, & actively participated in Sponsor conferences, PSSVs, SIVs
  • Retained many duties of previous role (Subject Recruitment Manager) in new capacity
Subject Recruitment Manager, 04/2016 to 01/2019
CNS Network – Long Beach, CA
  • Top producer based on subject recruitment and retention statistics (2016/2017) - Promoted from Recruitment Specialist to Department manager within 1 year of hire
  • Increased department rate of subject enrollment by 150%, while streamlining workflow, providing staff re-training, and introducing novel recruitment strategies
  • Managed daily operations of Neurology Outreach Department, overseeing up to 10 direct reports. Provided ongoing protocol training and staff coaching. Hired, trained, disciplined, and evaluated employee performance
  • Developed unique recruitment/retention strategies while managing each study from start to finish (averaging 30 trials at a time)
  • Built and maintained collaborative relationships with all study personnel (investigators, study coordinators, research assistants, and affiliated physicians/consultants), and ensured all critical milestones were achieved ahead of schedule
  • Developed study level recruitment materials and reviewed all site specific materials to align with trial and company messaging. Organized regular community outreach events to stay industry relevant
  • Assessed feasibility of proposed Phase I-IV trials, and acted as liaison between study team and business development. Maintained communication with sponsor/CROs regarding study progress, and provided leadership during PSSV, and SIVs. Provided feedback on study design, and need for protocol amendments. Represented site at Investigator Meetings, Study Kick-Off, Re-Set meetings
  • Developed and managed reports for communicating study progress and key metrics to Executive Team
Other Relevant Work History

iHelp Globally, Co-Founder and Director (Apr 2012-present) - Latin America

  • Manage multiple cross-functional end-to-end projects across multiple time zones (to successfully carry out international medical campaigns in underserved communities)

Arrowhead Regional Medical Center, Fiscal Associate (Apr 2012 - Sep 2015) - Colton, CA

  • Billing/Coding of Medicare claims for inpatient and outpatient services

El Camino Hospital, Patient Registrar II (Oct 2009 - Feb 2012) - Los Gatos, CA

  • Interviewed and collected patient demographics and insurance information, while discussing payment options

Davis Fertility Center, Patient Relations Coordinator (Apr 2007 - Dec 2007) - Davis, CA

  • Performed new patient consultations regarding methods of achieving fertility

Advanced Laser Clinic, Patient Care Coordinator (Aug 2004 - Oct 2005) - San Jose, CA

  • Performed client consultations (non-invasive laser procedures) and provided operational statistic support
Education
Bachelor of Science: Neurobiology, Physiology, & BehaviorUniversity Of California - Davis, CA
Certificate: Clinical Trial Administration (40 Hours) - 2017University Medical Center Utrecht, Netherlands

Drug dev. process, ICH/FDA regulations; Trial design/protocol; EC/IRB; IP pipeline; GCP; Data analysis and reporting; Monitoring; Closeout.

Certificate: Clinical Trials Monitoring Workshop (80 Hours) - 2017University Medical Center Utrecht, Netherlands

Risk based monitoring; FDA/European regulations; EMA, CTA, Eudract; Philosophy of science; Pharmacoeconomics.

Certificate: Emergency Medical Technician - 06/2009University Of California, Davis
Languages
Bilingual (Russian/English); Working knowledge of Spanish.
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Resume Overview

Companies Worked For:

  • Cogniciti
  • CNS Network

School Attended

  • University Of California
  • University Medical Center Utrecht, Netherlands
  • University Of California, Davis

Job Titles Held:

  • Manager, Retention Optimization & Quality
  • Early Phase Project Manager
  • Subject Recruitment Manager

Degrees

  • Bachelor of Science : Neurobiology, Physiology, & Behavior
    Certificate : Clinical Trial Administration (40 Hours) - 2017
    Certificate : Clinical Trials Monitoring Workshop (80 Hours) - 2017
    Certificate : Emergency Medical Technician - 06/2009