Pavel Nikonov

Pavel Nikonov Email and Phone Number

Senior CRA @ ACCELLENA R&D
Paris, FR
Pavel Nikonov's Location
St Petersburg, St Petersburg City, Russia, Russian Federation
Pavel Nikonov's Contact Details

Pavel Nikonov personal email

n/a
About Pavel Nikonov

I am a Medical Doctor with specialization in internal medicine. Most of my experience is within clinical research industry (over 10 years of experience in different roles). Have extensive knowledge of the drug development lifecycle across various functional areas. In addition to clinical monitoring, I held administrative positions where learned a lot in management, HR, financial and legal aspects.My leading skills are analytical mindset, problem-solving and interpersonal relationships. This helps to achieve complex and long-term goals in cross-functional interaction.

Pavel Nikonov's Current Company Details
ACCELLENA R&D

Accellena R&D

View
Senior CRA
Paris, FR
Website:
accellena.com
Employees:
34
Pavel Nikonov Work Experience Details
  • Accellena R&D
    Senior Cra
    Accellena R&D
    Paris, Fr
  • Medpace
    Principal Clinical Research Associate
    Medpace Jan 2020 - Oct 2023
    Melbourne, Victoria, Australia
    • Serve as a Lead CRA (global and regional), acting as the primary contact for monitoring related questions and Monitoring Plan development/maintenance; • Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams and vendors;• Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirements; • Ensure site compliance according to protocol and applicable regulations;• Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, Medpace/Sponsor SOPs, and applicable regulatory requirements; • Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases;• Assist with regulatory submissions and site start-up.
  • Biomapas
    Senior Clinical Research Associate
    Biomapas May 2017 - Dec 2019
    Saint Petersburg, St Petersburg City, Russia
    • Made submissions to the Regulatory Authorities and Local Ethics committees, including initial and substantial clinical trial applications, export license submissions, and safety submissions;• Prepared and facilitated negotiations of clinical trial contracts with investigators and institutions;• Performed feasibility of new sites;• Monitored study sites for compliance with a study protocol, ICH-GCP, Sponsor's SOPs, and applicable regulations;• Translated, organized, and oversaw the translation process of required documents according to the competence;• Mentored newly assigned and less experienced CRAs and performed accompanied visits.
  • Biomapas
    Country Manager
    Biomapas Feb 2018 - Sep 2019
    Russian Federation
    • Performed administrative and HR activities, such as interview of candidates, supervision of accountancy, negotiation, preparation and execution of vendor contracts;• Represented the companies services (Clinical Operations, Pharmacovigilance and Regulatory Affairs) at conferences and conducted face-to-face meetings with clients;• Planned expenses for the coming month to ensure seamless operations and avoid potential overturns/overspends;
  • Blackwood: Photo & Video Production Studio
    Studio Owner / Photographer
    Blackwood: Photo & Video Production Studio Apr 2016 - Aug 2017
    Saint Petersburg, St Petersburg City, Russia
    • Operated the studio by performing marketing, sales, contract negotiations, finances, and budgeting• Developed the company website (zero-coding solution Tilda) and integration with CRM• Managed advertising in Google Adwords and Yandex Direct• Performed photographer and retouch responsibilities
  • Medpace
    Cra Ii
    Medpace Feb 2012 - Apr 2016
    Saint Petersburg, Russian Federation
    • Performed all types of monitoring visits in following therapeutic areas: Oncology, Cardiology (hypercholesterolemia trials), Rheumatology, Urology and Dermatology.• Prepared sites for audits.• QC'ed TMF (country and site levels)• Made feasibility of new sites;• Negotiated contracts with Institutions and Investigators;• Translated and reviewed study documents (Protocols, ICFs, IBs, contracts etc.)• Held local Lead CRA (support to other Russian and Ukrainian CRAs).
  • Accell Clinical Research, Llc
    Clinical Research Associate
    Accell Clinical Research, Llc Jan 2011 - Feb 2012
    Saint Petersburg, Russian Federation
    • Conducted pre–study, initiation, and monitoring visits according to SOPs and Good Clinical Practice (GCP)• Performed feasibility analysis of potential sites• Oversaw site management for assigned sites• Completed visit reports and maintained study–related Trial Master Files and databases
  • Petersburg Hotels
    Search Engine Optimization Specialist / Interior Photographer
    Petersburg Hotels Mar 2006 - Mar 2009
    Saint Petersburg, St Petersburg City, Russia
    • Reviewed and editing content throughout company’s websites • Assisted in web-sites development from SEO perspective• Developed semantic core for the assigned projects• Made interior photographs of hotels and apartments

Pavel Nikonov Skills

Ich Gcp Clinical Research Clinical Trials Clinical Monitoring Cro Protocol Sop Medicine Therapeutic Areas Clinical Research Associates Cardiology Ctms Edc Gcp Commercial Photography Fine Art Photography

Pavel Nikonov Education Details

  • North-West State Medical University Named After I. I. Mechnikov
    North-West State Medical University Named After I. I. Mechnikov
    Certified Md
  • Epam Upskill
    Business Analysis
  • North-West State Medical University Named After I. I. Mechnikov
    North-West State Medical University Named After I. I. Mechnikov
    4.75 Of 5 (Degree With Honors)

Frequently Asked Questions about Pavel Nikonov

What company does Pavel Nikonov work for?

Pavel Nikonov works for Accellena R&d

What is Pavel Nikonov's role at the current company?

Pavel Nikonov's current role is Senior CRA.

What is Pavel Nikonov's email address?

Pavel Nikonov's email address is bl****@****ndex.ru

What schools did Pavel Nikonov attend?

Pavel Nikonov attended North-West State Medical University Named After I. I. Mechnikov, Epam Upskill, North-West State Medical University Named After I. I. Mechnikov.

What are some of Pavel Nikonov's interests?

Pavel Nikonov has interest in Photography, Sports, Medicine (Especially Oriental One), Philosophy.

What skills is Pavel Nikonov known for?

Pavel Nikonov has skills like Ich Gcp, Clinical Research, Clinical Trials, Clinical Monitoring, Cro, Protocol, Sop, Medicine, Therapeutic Areas, Clinical Research Associates, Cardiology, Ctms.

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