DAOUT Nicolas
CV Nicolas DAOUT 2022
Solid & Hard worker
Agile & Flexible
Positive & Supportive
Team player
Bold and Practical
44 years old
Driving License
Professional Status
Employed
Open to opportunities
About Me
20 years’ experience in Clinical Research working on projects from Phase I to IV.
Roles have included the following positions: Clinical Technician; Clinical Research Associate (CRA); Senior in house CRA, Line Manager, In-house Clinical Research Specialist, Global Clinical Project Manager (CPM) and Project Vendor Manager (PVM).
Experienced in a wide range of Therapeutic areas including: Rheumatology, Multiple Sclerosis, Diabetes, Neuropathy and Cardiovascular as well as in ePRO/eCOA and Rating Scales Training category of services.
Currently working partially as a Vendor Category Manager (VCM) leading and overseeing the management of Central IRBs vendor category(s) of services.
Second part is dedicated to actively support the Vendor Management Office head (as Deputy) in optimizing and maturing the department’s vision.
Roles have included the following positions: Clinical Technician; Clinical Research Associate (CRA); Senior in house CRA, Line Manager, In-house Clinical Research Specialist, Global Clinical Project Manager (CPM) and Project Vendor Manager (PVM).
Experienced in a wide range of Therapeutic areas including: Rheumatology, Multiple Sclerosis, Diabetes, Neuropathy and Cardiovascular as well as in ePRO/eCOA and Rating Scales Training category of services.
Currently working partially as a Vendor Category Manager (VCM) leading and overseeing the management of Central IRBs vendor category(s) of services.
Second part is dedicated to actively support the Vendor Management Office head (as Deputy) in optimizing and maturing the department’s vision.
Skills
General skils
- Department Strategy & Vision
- Process Improvement / Lean mindset
- Finance / Reporting
- Innovating vision & mindset
- Presentation and Communication skills
- Vendor Management (Project and Governance level)
- Line management
- Resourcing / staffing
- Clinical experience / ICH/GCP
- Problem solving
- ICH/GCP quality
- Clinical Technician skills (Blood samples, ECG and manual reading, vital signs measurement and analysis, Tremor measurement and analysis, platelets aggregation)
Experiences
Vendor Management Office deputy Head
IQVIA
Since March 2021
- Drive VCMs onboarding (including creation of VCM training guide, development and review of materials, scheduling, conduction ...)
- Development of VMO department communications (external and internal introduction, Virtual IQVIA conference booth materials, Dep. SharePoint com., promotion cross IQVIA entities, Dep. Case Study, point of contact for project vendor management center of excellence, ...)
- Implementation of VMO department tools such as operational support/escalation tools, Data collection system of Vendor use, Smartsheet use, VMO PowerBI dashboard...
Including: establishment of requirements, technical specifications, testing, communications, metrics, reconciliation, ... - Financial VMO department (report creation, across system reconciliation, Snr Leadership reporting)
- Initiative led: Operational vendor satisfaction survey; department FAQ, Snr Leadership category governance meeting and vendor cyberattack.
Support on: cross functional RACI and KPIs (category and department level)
Vendor Category Manager (VCM)
IQVIA
Since July 2020
- Establish oversight plans to proactively manage vendor performance, governance, KPI tracking and quality improvement across assigned categories
- Review consolidation of spend, evaluate overall category risk and business continuity planning and ensure compliance for onboarding for vendor(s) and integration to IQVIA network portfolio
- Provide:
- support for Project Leadership teams as a SME within each vendor assigned category
- proactive management across category(s) of vendors and be primary contact for vendor advice and expertise
- category management, including consolidation of vendors, overall risk management and business continuity planning
- support for Project Leadership teams as a SME within each vendor assigned category
- Responsible for the identification of additional offerings from existing in-network vendors
- Implement and maintain Vendor and Category Oversight plans
- Administration of project level contracts
- High level invoice tracking and escalation point for invoice issues
- Category of Services: ePRO/eCOA & Rating Scales Training until Oct 2021
- Category of Services: Central IRBs (curent)
COVID-19 TRIAGE TEAM
IQVIA
April 2020
to July 2020
Full-time
France
- Establish or Adjust current or new Vendor services to align with project Covid-19 risk mitigation plan
- Prepare, present Covid-19 Vendor offering and collect project team expectations (including timelines for implementation)
- Create tracking/reporting tool and provide input to upper management of Vendor Services implementation
- Serve as primary project leader contact with Vendors to ensure communication is maintained and reporting schedules are adhered to
- Guide project teams through all vendors and Capacities versus project design and needs
- Manage, follow and support project team implementation of vendor services (including and not limited to meetings, documentation needs, quotation, services implementation…)
Global International Clinical Project Manager
IQVIA
August 2011
to April 2020
Full-time
France
- Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures,
- Manage and co-ordinate Vendor & Third Parties, System specification & Test versus protocol, project & customer needs,
(from Nov 2016 to Apr 2020) - Create project training material related to central monitoring activities, systems and processes and deliver training to CRAs/in house CRAs (iCRA)/CTAs as required throughout the project lifecycle,
- Lead problem solving and resolution efforts to include management of risk, contingencies and issues,
- Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, department Instructions, quality standards and expectations, per contract and priorities,
- Provide input for the development of proposals for opportunities; manage project budgets and revenue & recognition,
- Analyze compliance and project reports to assist with this oversight and timely completion of tasks.
- Participate and assist iCRAs/CRAs/CTAs in the preparation of site/in-house audits and in creation of Corrective Action Plans,
- Provide input to the Clinical Project Manager (CPM) on central monitoring requirements during the development of the Integrated Project Management Plan/Clinical Operations Plan,
- Ensure that all required department guidelines for central monitoring activities are set up and updated as required,
- ICH/GCP Knowledge; Recruitment management; Source document management, safety report, data quality check, Query resolution
- Manage resources and training of project teams,
- Regional Lead from Aug-2011 to Nov-2013
Global CPM from Nov-2013 to Nov-2016
Line Manager
IQVIA
April 2009
to August 2011
Full-time
France
- 16 Direct Reports (remotely or face to face),
- Career Management: Project support; Resourcing; One to one, staff performance review, Interview,
- Trainer: Inspection Readiness Training; Workshop ICH/GCP; Department Presentation / Development of Inter-Departmental Synergy
- Department initiative: Coaching Mentoring Program; WE Resourcing call & Meeting; Business Fundamental knowledge Assessment
Senior on site / in house Clinical Research Associate
IQVIA
October 2006
to April 2009
Full-time
France
- Clinical Trial:
- Acute Coronary Syndrome: Ph III, 56 countries (US; WE; EE; Asia), 400 Sites, 15.600 pts
- Type II Diabetes: Ph III, 22 countries (WE; EE); 102 Sites, 4.000 pts
- Allergic Rhinitis: Ph II, 10 countries (WE); 52 Sites, 630 pts
- Acute Coronary Syndrome: Ph III, 56 countries (US; WE; EE; Asia), 400 Sites, 15.600 pts
- During enrolment phase: remote site support and management, recruitment ,
- During project maintenance: onsite monitoring visit, Audit, Source data verification, remote site support and management, Queries resolution, site closure
- Senior position from Oct 2007
Technician / Clinical Research Associate
ASTER-CEPHAC
October 2001
to April 2006
Full-time
France
- Clinical Trial: Phase I (France - CRA role from 2004)
- CNS - Psychiatry - Pain - Alzheimer
- Cardiology
- Internal Medicine - Inflammatory - Infection
- CNS - Psychiatry - Pain - Alzheimer
- Internal set-up of phase l study, EC submission (including ICF management), e-CRFs, declaration of intent; Follow-up: Management of recruitment, data quality check, safety reports, samples and source documents; queries and monitoring,
- Key sponsor contact, close collaboration with investigator, local lab, volunteer recruitment department,
Education
Lean Sigma Practitioner
Since 2020
Barnett Accreditation – Fundamental GCP Exam, 2020
2020
Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites
2010 & 2012 & 2014 & 2016
Bachelor’s Degree
October 2002
to June 2003
Statistical methodology & Clinical Project Management
Associate's Degree
September 1998
to June 2000
Biochemistry & Bioengineering, Molecular Biology, Cellular Biology, Microbiology (including practice).
Baccalaureate / High School Diploma
September 1997
to June 1998
Interests
Language
- French (native speaker), English: fluent
Technology
- Advanced MS Office user: Word, Excel, Powerpoint, MS Project, ...
Sports
- Swimming, Skiing, Running and Thaï Boxing
Travel
- Canada, England, United States, Guadeloupe, Turkey, Spain, Crete, Corsica, Vietnam
