Michael Tolle, JD, MBA

Experience

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  DEG

  Sept 2006 - Sept 2007

  Specialist Portfoliomanagement Latinamerica

  - perception of controlling functions in the field of project monitoring- review of credit securities in special risk classes-safety data maintenance-monitoring of contractual obligations from loan agreements and problem loans-check disbursement of credit documents-special functions

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  PRA International

  Sept 2007 - Dec 2009

  Contracts Associate

  managing contract and budget negotiations for clinical trial; responsible for Clinical Tial Agreements in German speaking countries and Eastern Europe;adapting budgets for Site specificsolutions; negotiation of other agreements like country coordinator, study nurse, pharmacy, laboratory, pathology and radiology contracts. Supporting Clinical Team in EC submission proccess and act as country specific legal expert.

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  PPD

  Jan 2010 - Jul 2012

  Contracts Specialist

  draft, review and negotiate agreements with clinical study sites and principal investigators("Clinical Trial Agreements"); serve as primary contact for investigators, study sites and sponsor in relation to contract and budget for assigned studies; manage agreements in different EAPA countries ; close relationship with all internal departments.

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  United BioSource Corporation

  Aug 2012 - May 2014

  Contracts Manager

  Manage clinical study contracts and budgets. Liase with relevant project team (internal departments and sponsors) to ensure contract management support throughout the life of the project. Plan, initiate, and negotiate contracts and budgets directly with study-related vendors and study-related consultants. Manage third- party vendors performing contract negotiations on behalf of UBC.

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  INC Research

  Jun 2014 - Dec 2017

  Manages administration and negotiation processes for site contracts that support projects within Clinical Operations. Ensures site contract documentation is in compliance with sponsor and Company requirements.Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Supervises and coaches site contract staff and identifies ways to improve internal projects operations. Establishes strong working relationships with customers and internal project teams. Leads internal team education and process improvement initiatives.Participates in business development presentations as a subject matter expert in processing site contracts within the Company. Linemanagement for a group of German and Swedish Contract Specialists and Contract Analysts. Show less

  • Associate Director, Study Start Up & Regulatory - Global Site Contracts Service Centre

    Nov 2017 - Dec 2017

  • Manager, Site Start-Up & Regulatory

    Nov 2016 - Oct 2017

  • Manager, Site Contracts

    Jun 2014 - Oct 2016
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  Syneos Health (Previously INC Research/inVentiv Health)

  Jan 2018 - Jul 2021

  Associate Director, Site Start-Up and Regulatory - Site Contracts Service Center

  overseeing global Project Set Up process for Site Contracts;line manager for a team of Project Set Up Leads and Site Contract Leads;overseeing and maintaining our global Site Contracts Intelligence tool (includes keeping Site Contracts up-to-date with actual legislation and regulations);internal and external point of contact for Site Contract related queries;SME for Investigator Contract and Budget Set-Up;supporting Help Desk Services in relation to Site Contracts and GDPR.functional responsibility for training and resourcing. Show less

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  Syneos Health Clinical Solutions

  Aug 2021 - May 2023

  Associate Director Study Start-Up and Regulatory - Syneos Operations Network

  leading our centralized CTA QC and CTA Amendment Hubs in Serbia and Argentina :Together with additional Managers I am overseeing a team of 60 People dedicated to CTA Amendment work- including functional - and line management:

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  ICON Strategic Solutions

  May 2023 - Oct 2023

  Sr. Contract & Budget Negotiator

  working as Contract and Budget Negotiator in FSP - in charge of drafting, negotiating and processing Contracts and Budgets for Clinical Studies

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  ICON Strategic Solutions on behalf of Pfizer

  Nov 2023 - now

  overseeing Site Contract activities for Slovakia and Czech Republic, guidance and mentoring of local Investigator contracts team, supporting milestone planing and country activities in relation to Site Contracts

  • Regional Contracts Lead

    Dec 2024 - now

  • Investigator Contracts Transition Manager

    Nov 2023 - Nov 2024