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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
Scientific Project Manager, 12/2019 to Current
Endeavor Consulting Group – Boston
  • Promoted from Associate Project Manager, December 2020.
  • Scientific Project Manager (PM) leads operational study team, manages key relationships with internal and external stakeholders and oversees all aspects of given project to ensure successful execution.
  • While proactively managing study timelines, PM adequately evaluates probability and impact of risk, develops and implements risk management plans to mitigate effect on project objectives and deliverables.
  • PM effectively navigates project budgets towards expected profitability.
  • Facilitates project team meetings, cross-functional communication and decision-making to align with internal/external stakeholders.
Manager, Retention Optimization & Quality, 01/2019 to 10/2019
Cogniciti – City
  • 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 KPIs, 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
  • Built and maintained strong relationships with external contacts (pharmaceutical sponsors, private and academic clinical trial sites) to ensure that research subject referrals were handled responsibly



Early Phase Project Manager, 10/2018 to 01/2019
CNS Network – City , STATE
  • Promoted from Subject Recruitment Manager.
  • Management of operational aspects of Phase II-IV clinical trials from study start-up, while adhering to protocol, GCP, SOPs
  • Assessed feasibility (recruitment capability, timelines, vendor and equipment access, staffing), to ensure 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
  • Managed/facilitated weekly business development meetings, & actively participated in Sponsor conferences, PSSVs, SIVs
Subject Recruitment Manager, 04/2016 to 01/2019
CNS Network – City , STATE
  • 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
  • Built and maintained collaborative relationships with all study personnel (investigators, 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, SIV, KOM.
  • 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 (to successfully carry out international medical campaigns)

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
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/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
Bachelor of Science: Neurobiology, Physiology, & Behavior, 06/2009
University Of California - City, State
Languages
Bilingual (Russian/English); Working knowledge of Spanish.
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Resume Overview

School Attended

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

Job Titles Held:

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

Degrees

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

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