Alimatu D.

Experience

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  Liberty Mutual Insurance

  Aug 2002 - Feb 2008

  Legal Secretary

  Provided secretarial support of a legal nature for two to three staff attorneys maintaining a close and highly responsive relationship to the day-to-day activities of said attorneys. Communicated effectively with courts, judges, attorneys, and policyholders. I edited, proofread, and prepared legal documents. Drafted routine contracts and/or legal agreements and researched the background information related to the legal issues. Led projects to train colleagues in new program software from the home office. My end point was to have them fully trained and use the program efficiently. Show less

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  Burger King Corporation

  Feb 2008 - Aug 2008

  Legal Assistant

  Provided support of a legal nature for the Legal Director and maintained a close and highly responsive relationship to the day-to-day activities of the director Communicated effectively with different business clients both and with department heads within the organization. Responsibilities included drafting, revision, and processing of contracts with vendors, compiling weekly/monthly metrics, preparing reports, edit, and proofread legal documents, preparing power point presentations, working and leading special projects within the department, and compiling financial data. Attended meetings and participated where active negotiations were being held. Show less

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  Boehringer Ingelheim

  Jun 2015 - Jun 2016

  Contract Negotiator/YOH Contractor providing support to Boehringer Ingelheim

  Diverse, results-driven role in fast-paced environment involving:•Preparation, and negotiation of clinical contracts, amendments, and other documents in accordance with corporate policies, SOPs, and industry regulations•Negotiation and management of complex clinical trial budgets while taking care to minimize business financial risk and stay within fair market value parameters•Review contract language and prepare standardized and routine alternative language responses to negotiate contract modifications.•Communicate contract policies to clinical & business teams. •Ensure contract review, approval, and execution in accordance with established corporate processes and guidelines.•Participate in the Clinical Trial Team Meetings to ensure timelines are achievable and contract status is accurately reflected within the CTMS and Portal systems. •Clinical budget development for oncology, respiratory, metabolism and CNS Therapeutic Areas•Interaction across multiple therapeutic areas and product lines to ensure timely, responsible and successful contract generation, administration, and management to accomplish business objectives; produce monthly metrics outlining the progress of trial initiation and other key performance indicators•Liaise between and function within legal, clinical, business, and regulatory departments•Work with a team to develop process flow improvement and promote ongoing productivity increases•Ensure adherence to ICH GCP, FDA Regulations, and BI SOPs/Local Working Instructions•Coordinate contract review with Legal and Contract Operations•Monitoring project risks to identify potential problems and proactively identifying solutions to address them in advance.•Monitoring staff & team performance with weekly or biweekly team meetings.•Escalating promptly any issues that may affect operations. •Deliver strategic direction during the implementation stages. •Grant Manager Show less

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  ExecuPharm

  Jun 2016 - Apr 2017

  Contract Manager on assignment to Boehringer Ingelheim

  Diverse, results-driven role in fast-paced environment involving:•Preparation, and negotiation of clinical contracts, amendments, and other documents in accordance with corporate policies, SOPs, and industry regulations•Negotiation and management of complex clinical trial budgets while taking care to minimize business financial risk and stay within fair market value parameters•Review contract language and prepare standardized and routine alternative language responses to negotiate contract modifications.•Communicate contract policies to clinical & business teams. •Ensure contract review, approval, and execution in accordance with established corporate processes and guidelines.•Participate in the Clinical Trial Team Meetings to ensure timelines are achievable and contract status is accurately reflected within the CTMS and Portal systems. •Clinical budget development for oncology, respiratory, metabolism and CNS Therapeutic Areas•Interaction across multiple therapeutic areas and product lines to ensure timely, responsible and successful contract generation, administration, and management to accomplish business objectives; produce monthly metrics outlining the progress of trial initiation and other key performance indicators•Liaise between and function within legal, clinical, business, and regulatory departments•Work with a team to develop process flow improvement and promote ongoing productivity increases•Ensure adherence to ICH GCP, FDA Regulations, and BI SOPs/Local Working Instructions•Coordinate contract review with Legal and Contract Operations•Monitoring project risks to identify potential problems and proactively identifying solutions to address them in advance.•Monitoring staff & team performance with weekly or biweekly team meetings.•Escalating promptly any issues that may affect operations. •Deliver strategic direction during the implementation stages. •Grant Manager Show less

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  Regeneron Pharmaceuticals, Inc.

  Apr 2017 - Oct 2018

  Site Budget & Contract Specialist

  Ensure the accurate, timely, and completeness of required Clinical Site Budget development and Contract execution through the engagement of internal stakeholders and supplier.• Prepare Investigator site contracts, negotiate any requested changes based on Regeneron's business requirements, coordinate contract review with internal customers and work with Legal department to finalize contracts.• Manage site relationships and issue resolution of moderate to high complexity.• Manage changes to study scope ensuring timely contract amendment and implementation. Member of cross-functional teams; lead mtgs. as appropriate and influence line functions.• Updates tracking system with site contract data in an electronic library.Interact with internal customers; prioritize assignments.Responsible for making timely decisions & direction of outcomes.• Train & coach others site contracting processes and industry practices Show less

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  Loxo Oncology at Lilly

  Oct 2018 - Jan 2023

  Managing the contract life-cycle of various agreements with respect to all clinical site contracts, clinical trial vendor sourcing, Request for Proposal (RFP) process, financial review, and management of vendor relationships.• Negotiate Clinical Trial, Single Patient Protocol, Investigator Initiated Study, Confidentiality, and Vendor Agreements. • Review of protocols/protocol amendments to create and maintain Global Investigator Grant with the use of Medidata Grants Manager • Manage CRO teams for global clinical trials; as well as facilitate site relationships and issue resolution of varying complexity.• Review of Informed Consent Forms as appropriate for various clinical research studies to ensure compliance with regulations• Perform financial analysis, forecasting, and comparison, with the use of Oracle ClearTrial.• Establish discount and strategic partnership arrangements with key vendors to maximize cost savings and drive efficiency and consistency throughout vendor relationship.• Identify cost savings opportunities and assist in scenario planning throughout the clinical development life-cycle.• Responsible for establishing and continuing to improve upon contracting and clinical sourcing framework including RFP and vendor selection process, contract request process, financial and legal approval process, and PO system maintenance process. Show less

  • Senior Associate Manager Clinical Contracts

    Sept 2020 - Jan 2023

  • Senior Contract Specialist

    Oct 2018 - Sept 2020
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  Eli Lilly and Company

  Jan 2023 - now

  Senior Manager Clinical Contracts

  Managing the contract lifecycle of various clinical site & vendor agreements, Request for Proposals, & management of vendor relationships for Phase I oncology studies. • Negotiate Clinical Trial, Single Patient Protocol, Investigator Initiated Study, Confidentiality, and Vendor Agreements. • Review of protocols/protocol amendments to create and maintain Global Investigator Grant with the use of benchmarking tools (i.e. Medidata Grants Manager )• Manage CRO teams for global clinical trials; as well as facilitate site relationships and issue resolution of varying complexity.• Creating Job Aids to assist in the onboarding and training of new hires to acclimate them to systems used by the organization • Improving processes and overcome any inefficiencies within the current contracting process. • Creating and update legal language and budget playbooks used by the CRO teams • Design and implementation of Contract Management System• Review of Informed Consent Forms as appropriate for various clinical research studies to ensure compliance with regulations• Perform financial analysis, forecasting, and comparison, with the use of Oracle ClearTrial.• Establish discount and strategic partnership arrangements with key vendors to maximize cost savings and drive efficiency and consistency throughout vendor relationship.• Identify cost savings opportunities and assist in scenario planning throughout the clinical development lifecycle.• Responsible for establishing and continuing to improve upon site contracting, vendor contracting, and clinical sourcing framework including the RFP and vendor selection process, contract request process, financial and legal approval process, and PO system maintenance process.• Negotiate and manage the life cycle of Early Development and Clinical Pharmacology Vendor Agreements• Leading and/or representing the department in special projects that require collaborations between different groups within the organization. Show less