Nana Yakoubov
Houston,TX
Summary
Innovative and results-focused clinical project manager with 15+ years of healthcare experience, and a demonstrated ability to lead clinical operations. Professional history emphasizes the importance of effective people management skills and communication, as well as quality data. Even-tempered and persuasive nature allows to easily negotiate.
Overview
9
9
years of professional experience
Work History
Sr. Manager, Clinical Operations
ACELYRIN, Inc
09.2023 - Current
- Lead global clinical trials, ensuring compliance with ICH-GCP and local regulations
- Lead the Clinical Study Team to facilitate effective decision-making throughout the trials
- Collaborate with stakeholders and manage CROs/vendors for timely, budget-compliant trial delivery
- Ensure quality and integrity of trials by overseeing protocols, study documents
- Drive process improvement in Clinical Operations and manage study-level issues effectively
- Participate in co-monitoring site visits for sponsor oversight, training, and regulatory adherence
- Develop clinical operational strategies and risk management plans for trial execution
- Review and author key study documents to support trial integrity and compliance
Project Manager II
Biorasi, LLC
05.2022 - 09.2023
- Managed complete project lifecycle from planning/start-up to execution/close-out
- Managed a team of 6 direct reports, including clinical trial assistants
- Oversaw internal and cross functional teams across various geographic locations
- Managed external vendor qualification and selection, as well as performance and delivery of services
- Ensured timely creation, maintenance, and quality check of Trial Master File (TMF)
- Monitored, controlled, analyzed, reported on project’s health (budget, timeline, resources, issues/risks)
- Oversaw site management and clinical operations team
- Performed periodic review of study documentation and conduct to ensure compliance with plans and SOPs
- Supported project acquisition activities
Scientific Project Manager
Altasciences | Formally WCCT Global, Inc
12.2019 - 05.2022
- Promoted from Associate Project Manager, December 2020
- Led operational study team; managed key relationships (internal/external); oversaw all aspects of project
- Proactively managed study timelines, and evaluated probability and impact of risk
- Developed and implemented risk management plans to mitigate effect on project objectives and deliverables
- Effectively navigated project budgets towards expected profitability
- Facilitated project team meetings, and cross-functional communication and decision-making to align with all stakeholders
Manager, Retention Optimization & Quality
Cogniciti
01.2019 - 10.2019
- Promoted from Research Engagement Expert, April 2019 - gaining autonomy over 8 direct reports.
- Hired, trained, and evaluated performance of staff
- Managed clinical project development to ensure data quality, integrity
- Set recruitment goals and provided regular coaching to Research Engagement staff (US, CA, UK)
- Surpassed forecasted KPIs (achieved all-time high randomization and enrollment retention rates by increasing quality of subject pre-screening efforts, and maintaining relations with sites)
- Maximized team knowledge and productivity by effectively providing training on protocol and target indication
- Monitored KPIs, developed risk mitigation strategies, and identified areas of operational improvement
- Developed training materials and learning solutions
- Monitored training through various evaluative methods to identify opportunities for improvement
- Built and maintained strong relationships with sites to ensure that research subject referrals were handled responsibly
Early Phase Project Manager
CNS Network
10.2018 - 01.2019
- Promoted from Subject Recruitment Manager
- Managed clinical operations at study start-up
- Assessed feasibility (recruitment, timelines, vendor/equipment access, resources), to ensure on-time deliverables
- 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 SSVs, SIVs, IMs
Subject Recruitment Manager
CNS Network
04.2016 - 01.2019
- Top producer: Subject Recruitment and Retention statistics (2016/2017)
- Promoted from Recruitment Specialist to Department manager within 1 year of hire
- Managed daily operations (overseeing 10 direct reports). Hired, trained, and evaluated performance
- Increased enrollment rate by 150%, while streamlining workflow, and introducing novel recruitment strategies
- Collaborated with internal/external stakeholders, while ensuring on-time deliverables
- Developed study level recruitment materials; Organized community outreach events
- Assessed recruitment feasibility of Phase I-IV trials; supported business development team
- Developed reports for communicating study progress and key metrics to Executive Team, and external stakeholders
Education
Certificate - Clinical Trial Administration (40 Hours) - 2017
University Medical Center Utrecht, Netherlands
Certificate - Clinical Trials Monitoring Workshop (80 Hours) - 2017
University Medical Center Utrecht, Netherlands
Certificate - Emergency Medical Technician - 06/2009
University of California, Davis
Bachelor of Science - Neurobiology, Physiology, & Behavior
University Of California
Davis, CA06.2009
Skills
- Knowledge of GCP, ICH, HIPAA
- High-Impact presentations
- Theory & Management of Clinical Monitoring
- Project Management
- Advanced Medical Terminology
- 7 yrs direct report management
Therapeutic Experience
- Phase I-IV experience: Ophthalmology, Dermatology, Immunology / COVID-19, Urology, Diabetes (I/II), Type 1 Allergies, Anemia, Osteoarthritis, Alzheimer's, Parkinson's, Multiple Sclerosis, Ataxia, Neurogenic Orthostatic Hypotension, Migraines, Fibromyalgia, PTSD, Anxiety, MDD, and others. Operational management experience of First In Human trials (including Bridging Trials)
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
- Performed billing/coding of Medicare/Medi-cal 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, and provided operational support
Languages
Bilingual (Russian/English); Working knowledge of Spanish.
Timeline
Sr. Manager, Clinical Operations
ACELYRIN, Inc
09.2023 - Current
Project Manager II
Biorasi, LLC
05.2022 - 09.2023
Scientific Project Manager
Altasciences | Formally WCCT Global, Inc
12.2019 - 05.2022
Manager, Retention Optimization & Quality
Cogniciti
01.2019 - 10.2019
Early Phase Project Manager
CNS Network
10.2018 - 01.2019
Subject Recruitment Manager
CNS Network
04.2016 - 01.2019
Certificate - Clinical Trial Administration (40 Hours) - 2017
University Medical Center Utrecht, Netherlands
Certificate - Clinical Trials Monitoring Workshop (80 Hours) - 2017
University Medical Center Utrecht, Netherlands
Certificate - Emergency Medical Technician - 06/2009
University of California, Davis
Bachelor of Science - Neurobiology, Physiology, & Behavior
University Of California
Similar Profiles
Aida TalbiAida Talbi
Project Manager/Corporate Facilities Operations Manager/Special Events Manager at ACELYRIN, INCProject Manager/Corporate Facilities Operations Manager/Special Events Manager at ACELYRIN, INC
Kristi GilyotKristi Gilyot
Medical Assistance at Delgado Cardiovascular AssociatesMedical Assistance at Delgado Cardiovascular Associates
Lilyana PerezLilyana Perez
Foreman at SK ElectricForeman at SK Electric
Laura Audrey Emagan TchokotcheuLaura Audrey Emagan Tchokotcheu
President at Womens Amputee Football Association Cameroon (WAFAC)President at Womens Amputee Football Association Cameroon (WAFAC)
Noemy LopezNoemy Lopez
Dental Office Manager at Gentle Dental CareDental Office Manager at Gentle Dental Care