Design and create tools to facilitate the intake, processing and completion of new and current clinical research contracts •Partner with teammates to align operations to support correct and accurate contract details•Communicate with clients as needed to address activities and reports•Operate and maintain effective contract portfolio management and repository of approved vendors•Conduct needs assessments and negotiate contracts aligned with business requirements•Review counteroffers and negotiate applicable terms effectively and expeditiously•Administer and support contract agreements in compliance with corporate regulations•Negotiate project scope of work; prepare scope changes, as necessary•Track timely execution of project deliverables and monitor contract compliance

Research Contract Management• Acted as a bridge between Biogen study leads conducting research and Biogen’s legal department• Supported contract negotiations based on approved fallback positions from legal department; escalated issues appropriately• Supported global teams, leveraging strong communication skills and cultural competency Contract Development & Execution• Led multicounty projects for participation in industry-sponsored clinical trials

Leadership Input• Trained and mentored new staff members on departmental standard operating procedures (SOPs) and ensured quality of teamwork products; also maintained and updated training material for site contract team•Actively participated in high-level discussions about company goals, departmental objectives, and specific project aimsContract Development & Execution•Led multi-country projects for participation in industry-sponsored clinical trials•Administered all contract management processes, including coordination with relevant protocols; informed consent; and institution, investigator, vendor, consultant, and customer agreement documents•Generated amended contracts and budget documents, preparing contract management documentation for projects, and streamlining the contract development process; regularly suggested creative ideas for improving internal workflows•Worked within the forecasted country and site on contract timelines and milestones, using SSU tracking system in real time•Performed quality control and arranged execution of CTAs, as well as archival of documents, into repositoriesCommunication & Collaboration• Established strong working relationships with SSU lead, customer, and internal project teams•Escalated deviations to department leadership and/or site contact, service center, or legal department as appropriate•Served as key communication liaison between site contracts organization and internal and external customers•Provided functional guidance and apprised internal and external teams of all contract statuses or pending issues Budget Oversight•Monitored basic budgetary and financial aspects of projects and the number of hours/tasks availableper contract•Escalated budgetary discrepancies to appropriate internal groups

Implemented a series of initiatives to incentivize consistent use of vendor processes, quality methodology, and best practices throughout the contract research organization’s operations.•Facilitated the end-to-end process for evaluating, selecting, and managing clinical vendors, includingpreferred vendors•Supported vendor start-up; ensured agreements included correct language, classification, timelines,and project scope• Represented PRA in governance meetings with vendors regarding performance, metrics, financial health, and process review•Identified and remediated vendor issues by implementing new training resources or driving smartprocess changes

Leading a team of junior contract managers, supported clinical biomedical research by independently negotiating and executing new contracts, including confidentiality, consulting, and clinical conduct agreements• Worked with clinical trial teams to ensure that all terms, budgets, and payment schedules were within approved guidelines•Negotiated site contract language in coordination with legal, IP, insurance, QA, data privacy, and finance teams•Followed up with contracting parties to report on status, then finalized contracts and signature capture via DocuSign

•Coordinated fulfilment of the commercial real estate firm’s contractual obligations •Managed, negotiated, interpreted, and analyzed corporate contracts and client service agreements for compliance, then ensure proper execution•Reviewed contract language and terms for compliance with legal guidelines, corporate standards, contracting best practices, budget and cost constraints, and client-side operating procedures•Wrote and evaluated proposals for new contracts or continuation of existing contracts, then offered award recommendations•Acted as the primary point of contact for clients seeking modification of or amendments to existing contracts•Interacted frequently with the accounting department regarding invoicing, insurance, or other financial issues

•Prepared confidential disclosure agreements (CDAs), clinical trial contracts, master service agreements (MSAs), and other contract types to support research and clinical trial activities •Served as the first-line negotiator with external parties regarding requested changes to proposed agreements and primary point-of-contact with the corporate law group, study teams, sites, procurement, and external parties•Collaborated with R&D and clinical trial teams to develop clinical trial agreements, resolved issues, secured agreements with investigators and site managers, and maintained appropriate documentation and records via contract management database•Worked in partnership with the in-house attorney team to develop, refine, and implement contracting templates•Developed research agreements, consulting agreements, software agreements, KOL agreements, and testing agreementsReason for the overlap in employment: Worked simulltaneously due to different shifts/schedules.

•Worked on complex financial, product liability, intellectual property, and commercial litigation cases via contracts with several third-party corporations and law firms•Reviewed multibillion-dollar corporations’ internal memoranda, emails, educational materials, and other documents for relevance to litigation, legal privileges, and privacy protections•Assisted corporate legal counsel and law firms during major litigation preparation; ensured accurate document series coding•Identified relevant subject matter for first-level review; found documents to escalate for further review via legal analysis•Provided accurate determinations for responsiveness, privilege, confidentiality, and appropriate redactions

•Guided end-to-end clinical outsourcing and contracting process, advising clinical client groups on due diligence and contract oversight•Led vendor evaluation and selection process through RFP•Drafted, negotiated, awarded, and administered contracts (including final approval of payment) and escalated progress/negotiation issues•Tracked contract progress, deadlines, and deliverables; requested and approved amendments or contract extensions•Led the vendor outsourcing (analysis of bid/budget responses); oversaw and audited vendor performance•Primary contact with vendors for negotiation of the scope of work, study assumptions, and budget on behalf of study team

• Managed the review and negotiation of contracts with investigators participating in clinical research on behalf of pharmaceutical sponsors. Assisted with the full lifecycle of contract/agreement preparation• Created and managed contract templates, prepared agreements, negotiated language, and reviewed final documents• Served as primary lead for all site contracts; maintained and tracked communications with sites and internal staff

•Responsible for managing commercial contracts for Johnson & Johnson as a Contractor in the IT and General Services Global Outsourcing Division. Duties include request for vendor management, analyzing bids, negotiating final contracts, and tracking cost savings•Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts and grants related to clinical trials•Contribute to improving processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites•Analyze contracts and identify areas of concern and/or contention prior to obtaining formal legal counsel advice

• Proactively increased performance by significantly revamping complex contract management processfor world-class, research-based $11 Billion pharmaceutical company, which employs more than 96,500 people in over 100 countries• Managed all aspects of day-to-day contract management activities in support of organizational goals• Applied strategic planning, prioritization, and project management skills toward consistently achieving critical deadlines• Trained, mentored, and supervised staff members, with strong focus on optimizing productivity and performance• Conducted data-based market research to drive strong growth in a rapidly changing healthcare environment• Lead manager with designated areas to facilitate understanding of client needs and to prepare with them appropriate solutions to meet their resourcing needs• Successfully researched and negotiated contracts and contract amendments in order to secure the organization’s position• Strategically planned and coordinated key contracts to ensure on-time, requirements-compliant completion while maintaining high quality standards• Proficiently managed all phases of day-to-day multi-party negotiations and disputes arising out of the contract procurement process• Diligently evaluated and negotiated low-risk agreements as well as performing feasibility and needs-analysis to benefit core pharmaceutical business, further illustrating exceptional analytical talents

Duke University Procurement Services provides comprehensive contracting and procurement services for the University, Duke University Health System, and Duke University Medical Center •Responsible for managing complex medical and biotechnology research contracts through inception to completion, with independent contracting authority for negotiation of final contract terms of multiple contracts, coordinating final contract terms with vendors and legal counsel•Performed in-depth analysis of legal, regulatory and contracting issues, researching organizations and principal investigators regarding ability to perform and meet contract requirements, timelines and deliverables•Provided guidance and direction to other contract staff in legal, regulatory and compliance issuesAccomplishments and Key Contributions•Responsible for leading team to develop and execute policy and procedures in response to Health Insurance Portability and Accountability Act of 1996 (HIPPA), conducting research and developing recommendations for contract compliance•Provided leadership and support to staff members in the development and execution of complex contracts, using experience and knowledge of legal, regulatory and procurement issues to develop and provide feedback to improve “value added” to organization