Cogniciti Resume Example Endeavor Consulting Group

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.

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

Cogniciti Resume Example

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