Investigator Contracts Lead I

4 semanas atrás

Brasil Parexel Tempo inteiro

Parexel FSP is looking Investigator Contracts Lead (ICL) in Brazil

Job Summary

The Investigator Contracts Lead (ICL) is responsible for direct site-facing contract and budget negotiations thought contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines though start-up.

Responsibilities

  • Exercise good judgment in balancing the risks for Sponsor in making budget and contractual decisions against the impacts to Sponsor clinical trial timelines.

  • Follow processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials.

  • Work with partners to develop and oversee the global site budget process.

  • Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters.

  • Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.

  • Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies.

  • Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space.

  • Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space.

  • Has knowledge of the principles, concepts and theories in applicable business discipline.

  • Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements.

  • Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline.

  • Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of business objectives.

QUALIFICATIONS Basic Qualifications

  • 5+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor's degree.

  • Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities.

  • Balance of general business, compliance, finance, legal, and drug development experience.

  • Precise communications and presentation skills.

  • Ability to plan, identify and mitigate risks to site contacting timelines.

  • Demonstrated ability to lead by influence rather than positional power to accomplish critical deliverables.

  • Demonstrated success in working in a highly matrix-based organization.

Preferred Qualifications

  • 2+ years of experience in clinical development operations or clinical trial outsourcing and a US Juris Doctorate or equivalent legal degree.

  • Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation.

#J-18808-Ljbffr

  • Senior Investigator Pricing Analyst

    3 semanas atrás

    Brasil Pharmaceutical Research Associates, Inc Tempo inteiro

    OverviewAs a Senior Investigator Pricing Analyst (Site Payments), you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.ResponsibilitiesWhat you will be doing:Senior Investigator Pricing Analyst (Site Payments) will undertake activities to provide specialized support and assistance to...

  • Senior Investigator Pricing Analyst

    4 semanas atrás

    Brasil ICON Strategic Solutions Tempo inteiro

    As a Senior Investigator Pricing Analyst (Site Payments), you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Senior Investigator Pricing Analyst (Site Payments) will undertake activities to provide specialized support and assistance to the Clinical Business...

  • Senior Investigator Pricing Analyst

    4 semanas atrás

    Brasil ICON Strategic Solutions Tempo inteiro

    As a Senior Investigator Pricing Analyst (Site Payments), you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Senior Investigator Pricing Analyst (Site Payments) will undertake activities to provide specialized support and assistance to the Clinical Business...

  • Site Activation Partner I

    4 semanas atrás

    Brasil Parexel Tempo inteiro

    Overview Parexel FSP is hiring multiple Site Activation Partner in Brazil. The Site Activation Partner (SAP) is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and...

  • Remote Rfp/contract Tender Manager

    3 semanas atrás

    Brasil Tomedes Ltd Tempo inteiro

    Builds market position by locating, developing, defining and closing business opportunities.- Identifies trendsetter ideas by researching and following industry trends internationally- Responds to RFP's, tenders and develops market in new sales territories to improve business growth- Screens potential business deals by analyzing market strategies, deal...

  • Senior Clinical Research Associate I

    4 semanas atrás

    Brasil Parexel International Tempo inteiro

    Parexel FSP is hiring multiple Sr CRAs in BrazilThe Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the...

  • Full Stack Technical Lead

    Há 6 dias

    Brasil Forsyth Barnes Tempo inteiro

    Job Title: Technical Lead – Full Stack Developer Industry: Fintech Location: Remote Contract: 6 Months We’re partnering with an innovative fintech company that is launching an intuitive, scalable mobile app. They’re looking for a Technical Lead with strong full-stack expertise to guide development, set best practices, and collaborate with...

  • Global Feasibility Lead II

    Há 6 dias

    Brasil Fortrea Tempo inteiro

    Job Overview The Global Feasibility Lead II will play an integral role in operational strategy and planning in the preaward space through participation in strategy development conversations, robust primary and secondary data collection and analysis, and development of feasibility and site selection strategies. In addition, the Global Feasibility Lead II...

  • Sr. Clinical Operations Lead

    4 semanas atrás

    Brasil Alimentiv Tempo inteiro

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associates (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Full Stack Technical Lead

    2 semanas atrás

    Brasil Forsyth Barnes Tempo inteiro

    💼 Job Title: Technical Lead – Full Stack Developer 💰 Industry: Fintech 📍 Location: Remote 🕒 Contract: 6 Months We’re partnering with an innovative fintech company that is launching an intuitive, scalable mobile app. They’re looking for a Technical Lead with strong full-stack expertise to guide development, set best practices, and...