* Build, maintain & manage strong Client and vendor relationships and understand client needs to help develop best solutions in meeting key vendor deliverables for their project* Work closely with outsourcing team on RFP development and execution, utilizing Fortrea qualified vendors for client’s specific trial needs* Review vendor proposals and contracts for inclusion of appropriate scope & pricing, obtain approvals and work closely with legal team to ensure all vendor contracts are processed on time* Create and maintain key performance documents including Vendor Management Plan, Project Management Plan, Communication plan, Data Management Plan, and vendor charters on assigned studies and obtain team and client approval* Participate in and present vendor processes and vendor updates in project meetings such as Kick-Off, Investigator, and ongoing Study/Client meetings * Serve as liaison between the operational project teams, Client and vendors by maintaining ongoing communication with assigned vendors, tracking status of service development and timelines, and escalating vendor-related issues as appropriate* Analyze vendor performance trends, perform proactive risk assessment, and provide timely issue resolutions and appropriate mitigation actions as needed* Negotiate new and amended work orders, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of vendors * Serve as governance lead for company preferred Translation vendors; participate and communicate important updates from meetings with greater Global Vendor Management group * Maintain status of vendor budgets versus actual spend, provide monthly update on budget statistics and ensure delineation of costs between task orders and change orders.* Track and file vendor management and vendor documents in eTMF system Veeva, according to eTMF guidelines and provide support with eTMF audits in quality vault

• Identifying, evaluating and qualifying of investigators; coordinate feasibility assessments; collect CDAs from sites and upload to client TMF portal.• Conduct co-monitoring oversight visits (Interim) to ensure CRAs are in compliance with FDA regulations, GCP/ICH guidelines for various small to medium life science clients. Train and mentor junior CRAs.• Set up and maintain study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory, or CRO• Review and approve monitoring visit reports of CRAs; provide support, training, and vendor metric reports to CRAs.

• Negotiated vendor and site agreements and budgets; managed the internal payment processes of vendors; provided invoice approvals through Navision invoicing system• Facilitated execution of vendor contracts (Lab, IP distribution, IVRS, Specialty Lab, Data Mgmt), ensuring proposals line up with Project CRO/Sponsor agreement on scope of work; ensure timely signoff of contracts with company legal team and vendor representatives• Tracked project metrics and financials in MS Project, includes updating project financial projections and reconciling with actuals.• Managed all aspects relating to vendors, including study budget, invoicing, project plan and vendor deliverables (User Acceptance Training, Data Specification Document)• Served as liason for all vendors; communicating effectively to study teams keeping them apprised of deliverable (contract and budget approval) and timeline status relating to study start date• Facilitated weekly meetings with vendors, presentation of vendor slides at investigator meetings

• Conducted all monitoring visits pre-study, initiation, interim and close out to Cromsource/Sponsor SOPs; performed 100% source document verification and electronic data capture at assigned sites• Managed assigned sites for Oncology Ph II and Respiratory Ph II by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements• Liaised with contractual vendors, Investigators, Study Coordinators, Cromsource clinical team and Sponsor team to ensure protocol is understood and followed by all parties so clinical data can be gathered without many queries• Completed timely monitoring trip reports and follow up letters to report on site’s progress, protocol deviations, regulatory document review, IP accountability, and follow up on outstanding action items from routine monitoring visits• Presented during department meetings, Investigator meetings and/or CRA calls; train and mentor Junior CRAs• Reviewed and managed data in EDC on site and remotely; resolves issues on a continuous basis to achieve timely database lock targets

See above description in Diversified Research on 07/19Performed same duties.

• Served and delivered the operational aspects of clinical studies from protocol feasibility, study start-up through database release• Provided day to day leadership to a team of 5 site managers, communicating study deliverables to be achieved• CRO management oversight of vendors of RAVE, IVRS, ePRO, Qlab, to include setting expectations, managing timelines of their deliverables, and issue management; review site payment status via vendor portal• Oversaw management of the trial by escalating site issues to global management as necessary • Reviewed and finalize trip reports of CRO CRAs; ensure site and monitoring quality,regulatory and GCP compliance; provided oversight management to a team of 8 CRAs• Provided team support for adjudication alerts, data management deliverables, preparation of meeting materials. Trained CRAs, site staff on adjudication process.• Maintained open lines of communication with multiple teams such as global, local, vendors and monitors to ensure successful completion of clinical trial endpoints are met• Ensured study milestones such as study start-up, execution, maintenance, analysis and close out are met through IMPACT CTMS system• Exercised use of electronic document management applications such as SharePoint, GEL and Veeva; managed/reconciled study TMF including training, QC, and ongoing management of TMF• Ensured SAEs are reported as identified in study protocol• Ensured sites are inspection ready at all times and support sites during inspections as necessary; follow up on audit/inspection findings

Travel to sites participating in clinical trial, ensure proper FDA & ICH/GCP guidelines being followed, follow up with detailed report outlining site's action items from site visit. Conduct Pre Study Selection Visits, Study Initiation Visits, Interim Monitoring Visits and Close out Visits in Oncology Ph II and CNS Ph III for this large CRO. Give slide presentations to assigned sites; designated contact person for the site to contact for any protocol questions and concerns; ensure site is following pharma company's protocol and perform routine monitoring visits to note any deviations from the protocol and notify site and governing IRB authority. Submit timely expense reports for site visits; submit timely trip reports and corresponding confirmation and follow up letters; conduct weekly telephone reports to all sites.

Travel to sites particpating in clinical trial, ensure proper FDA & ICH/GCP guidelines being followed, follow up with detailed report outlining site's action items from site visit.

Coordinated and negotiated clinical trial site contract and budgets between GSK and study centers in US Vaccines groupManaged the process and workflow of contracts and ensure proper routing of documents (ICFs) for execution by corporate officersCommunicate comments regarding contract language and status of agreements to internal clients, business partners and external partiesActed as subject matter expert that demonstrated an understanding of how contractual terms add value to internal and external customersLiaised with CROs/SMOs, clinical delivery team which included legal, and country operations team as directed to ensure all work is appropriately tracked in departmental and GSK global database in accordance with GSK guidelinesServed as point of contact for all vendor and site negotiations; communicating effectively to study teams keeping them apprised of deliverable (contract and budget approval) and timeline status relating to study start dateAttended sourcing strategy meetings, to determine the need to insource the site contracting function.

• Managed upto 16 sites in the US and Canada • Performed Pre-study, Initiation, Interim, Close-Out, and Accompanied Site Monitoring visits as needed in compliance with FDA regulations, GCP/ICH guidelines and Ockham SOPs for various Phase I and II CNS, Oncology, Cardiology and Anti-Coagulation clinical trials. • Solid ability to explain technical details of protocol, protocol amendments, and changes in ICF to investigator/study coordinator to keep them informed how these changes may affect the subjects and potential subjects in the study.• Primary contact and liaison for all study sites which included managing/answering questions on protocol procedures and patient eligibility issues.• Collaborated with CNS study team to develop creative advertising strategies for sites to aid in recruitment of subjects.

Developed relationships with key thought leaders, speakers and healthcare advocates to get products added to formulary for patients use and benefit. Gained exclusive formulary status in local hospitals of all products represented. Managed target industry segments, prepared forecasts, develop growth strategies, market trends, customer needs with competitive products and pricing. Presented In-Service programs to hospital departments such as Med/Surg, ICU, Emergency, CCU and Pharmacy on products and proper usage. Increased sales of medications by 50% in various therapeutic markets such as IV/PO Antibiotic, Anti-Hypertensive, Proton Pump Inhibitor, Hormone Replacement Therapy, Anti-Inflammatory to territory physicians and hospital personnel.