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With over a decade of experience in the clinical contracts field, I’ve developed an in-depth understanding of the complexities and nuances that come with navigating clinical research agreements. Currently, as a Senior Clinical Contracts Analyst at Parexel, I leverage my expertise to manage, negotiate, and optimize contracts that support groundbreaking clinical trials.Since starting my career in 2011, I have been deeply committed to facilitating processes that enhance efficiency and compliance while maintaining robust partnerships with sponsors, vendors, and internal stakeholders. My strengths lie in my keen attention to detail, strategic negotiation skills, and a proactive approach to problem-solving that helps keep projects on track.Beyond the contracts themselves, I’m passionate about fostering a collaborative environment, sharing knowledge with colleagues, and staying ahead of industry developments to ensure that our agreements meet the highest standards. If you’re looking for someone who thrives on complexity, values transparency, and is dedicated to the seamless execution of clinical contracts, let’s connect!
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Senior Clinical Contracts AnalystParexel Aug 2023 - PresentDurham, North Carolina, Us -
Contract ReviewerPlanet Pharma Apr 2023 - Aug 2023Deerfield, Illinois, Us -
Senior Clinical Contracts AnalystActalent Mar 2022 - Apr 2023Hanover, Maryland , Us• Responsible for development, negotiation, and processing of all global clinical site contracts (inclusive of budget creation/review) and investigator focused contract from Medical Affairs team• Mentoring and support of lower-level staff to manage clinical site contract process• Vendor management and CTA/Budget maintenance with CRO vendors for outsourced studies• Provides contracts and outsourcing support to internal & external stakeholders. • Assesses fair market value for budgets with guidelines provided by Compliance.• Assists clinical with direct negotiations and proposed changes to standard contract language with guidelines provided by legal• Liaises frequently with internal customers and stakeholders including the UT contracting process, PO process, external providers and the contracting environment.• Collaborate with functional groups within the company to ensure consistency of contract/payments across all studies.• Collaborates and liaises with CRO vendors while providing oversight on contract negotiations for outsourced studies. • Interacts with Clinical Research Associates (CRA) and Clinical Trial Leaders (CTL) to provide support needed for site contracts/budgets and Investigator site payments, as necessary.• Works with Legal, Compliance, Clinical Operations and Finance groups as liaison between functions.• Ensures that all study budgets are built and negotiated within Fair Market Value or provides sufficient documentation to obtain Compliance and study team approval. -
Sr Site Contracts LeadSyneos Health Mar 2021 - Mar 2022Morrisville, Nc, Us• May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials• Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template Submits proposed CTA and investigator budget for site review• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. • Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions• Identifies possible contract or process operational risk and proactively works within the team to provide solutions. Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues• Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. • Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs), and ensures quality of teamwork products Maintains and updates training material for site contract team• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion -
Clinical Contracts Associate IiAbbott Feb 2018 - Mar 2021Abbott Park, Illinois, Us• Perform a variety of activities involved in the drafting of contracts for clinical research studies• Monitor/review proposed contracts for compliance with applicable company policy as well as applicable regulations• Write technical contract language covering such issues as indemnification, subject injury language, intellectual property rights, confidentiality, fiscal/procedural constraints, and other similar matters• Maintain up-to-date Legal Department reference file Analyze and resolve technical problems of contract interpretation and resolves conflicts as necessary• Participate in policy discussions and recommends policy or procedural changes as appropriate; revise and update procedures as necessary• Monitors status of contracts for completion Information• Provides guidance to researchers for proposal development and submission by interpreting sponsor and university announcements and guidelines on application preparation and content by reviewing proposals for completeness and adherence to guidelines and mailing out proposals in timely manner• Provides grants management support to researchers by negotiating and processing awards, interpreting award conditions, obtaining approvals for award changes, and obtaining required reports• Drafts and negotiates contracts with various agencies (state and federal government, private organizations), pharmaceutical companies, and biotechnology companies to achieve agreements satisfactory to all parties, following state laws and Board of Regents' guidelines• Provides guidance and assistance to researchers as necessary for implementation and negotiation of research contracts, including sponsored research agreements and material transfer agreements• Searching directories and funding files, identifying, and matching sponsor with researcher, and mailing outperforms other duties as assigned -
Senior Grants And Contracts Specialist, ParalegalUt Southwestern Medical Center - Department Of Ophthalmology Apr 2016 - Feb 2018Gathers and provides information regarding funding opportunities and application procedures to researchers by reading newsletters and announcements, search directories, funding files, and other relevant resources. Provides guidance to researchers for proposal development and submission by interpreting and ensuring adherence to sponsor and university announcements and guidelines. Provides grants management support to researchers by negotiating and processing awards, interpreting award conditions, obtaining approvals for award modifications, and completing required reports. Negotiates contracts with various agencies (state and federal government, private organizations), pharmaceutical companies, and biotechnological companies to achieve agreements satisfactory to all parties. May draft entire contracts of various types following state laws and Board of Regents' guidelines. Provides working supervision to Grants and Contracts Specialist and administrative positions.
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Senior Grants And Contracts Specialist, ParalegalUt Southwestern Medical Center Feb 2014 - Apr 2016Dallas, Texas, UsGathers and provides information regarding funding opportunities and application procedures to applicants by reading newsletters and announcements, search directories, funding files, and other relevant resources. Provides guidance to researchers for proposal development and submission by interpreting and ensuring adherence to sponsor and university announcements and guidelines. Provides grants management support to researchers by negotiating and processing awards, interpreting award conditions, obtaining approvals for award modifications, and completing required reports. Negotiates contracts with various agencies (state and federal government, private organizations), pharmaceutical companies, and biotechnological companies to achieve agreements satisfactory to all parties. May draft entire contracts of various types following state laws and Board of Regents' guidelines. Provides working supervision to Grants and Contracts Specialist and administrative positions. Performs other duties as assigned. -
Grants And Contracts Specialist, ParalegalUt Southwestern Medical Center Nov 2011 - Feb 2014Dallas, Texas, UsProvides funding opportunity information to potential applicants by reading newsletters and announcements, searching directories and funding files, identifying and matching sponsor with researcher, and mailing out information. Provides guidance to researchers for proposal development and submission by interpreting sponsor and university announcements and guidelines on application preparation and content by reveiwing proposals for completeness and adherence to guidelines and mailing out proposals in timely manner. Provides grants management support to researchers by negotiating and processing awards, interpreting award conditions, obtaining approvals for award changes, and obtaining required reports. Drafts and negotiates contracts with various agencies (state and federal government, private organizations), pharmaceutical companies, and biotechnology companies to achieve agreements satisfactory to all parties, following state laws and Board of Regents' guidelines. Provides guidance and assistance to researchers as necessary for implementation and negotiation of research contracts, including sponsored research agreements and material transfer agreements. Monitors status of contracts for completion. Performs other duties as assigned.
Monique Young Skills
Monique Young Education Details
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Dallas Baptist UniversityManagement And Operations -
Everest College-DallasParalegal
Frequently Asked Questions about Monique Young
What company does Monique Young work for?
Monique Young works for Parexel
What is Monique Young's role at the current company?
Monique Young's current role is Senior Clinical Contracts Analyst.
What is Monique Young's email address?
Monique Young's email address is mo****@****lth.com
What is Monique Young's direct phone number?
Monique Young's direct phone number is +121454*****
What schools did Monique Young attend?
Monique Young attended Dallas Baptist University, Everest College-Dallas.
What are some of Monique Young's interests?
Monique Young has interest in Children, Economic Empowerment, Civil Rights And Social Action, Education, Human Rights, Health.
What skills is Monique Young known for?
Monique Young has skills like Proposal Writing, Budgets, Grants, Research, Negotiation, Public Speaking, Outlook, Contract Negotiation, Legal Research, Legal Writing, Newsletters, Data Analysis.
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