Experience

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  Providence hospital mobile

  Jan 2005 - Jan 2011

  Manager, oncology research

  Accomplishments:• Managed all solid and liquid tumor clinical trials. • Established regulatory and quality processes to conduct oncology clinical research.• Presented and examined solid tumor clinical research with local thought leaders.• Conducted investigator-initiated studies with direct reporting to the FDA. • Liaised between pharmaceutical medical scientists and local physicians to develop investigator initiated and applied research projects.

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  St. john health system

  Jan 2012 - Jan 2015

  Oncology clinical trials, director

  • Directed health system wide processes for sponsored oncology studies across four. affiliated hospitals. Initiated, managed and maintained BCBS breast cancer quality initiative-Michigan Breast Oncology Quality Initiative (MiBOQI).• Pioneered investigator-initiated studies and oncology research projects for oncology fellows. Liaised with key thought leaders on collaborative research consortiums.• Collaborated with Medical Science Liaisons from leading pharmaceutical companies on research studies. Guided and submitted grants, request for proposals.• Communicated with regulatory agencies FDA, OHRP and local regulatory bodies e.g., IRB. Oversaw operations for Oncology Research Department of staff of 10 full time employees and supported 9 oncologists.• Established metrics for meeting patient enrollment goals. Developed SOPs and work processes for regulatory and quality compliance.• Initiated and organized educational programs to support investigators and research staff. Focusing on ICH, FDA, OHRP and IRB regulations and guidelines. Created study tools, case report forms (CRFs), reported adverse events, protocol deviations and implementing corrective action for study initiation, duration and close-out.• Led infrastructure to build bio-repository requirements (collection, storage of fresh and paraffin embedded tumor tissues and specimens). Managed collection of clinical data for bio-specimens.• Delivered regulatory submissions to conduct investigator-initiated studies. Initiated and managed FDA interactions and negotiated clinical trial contracts.• Supervised accounting process for billing compliance, account for study payments, invoiced costs, tracking standard of care reimbursements to avoid double billing. Liaised between pharmaceutical medical scientists and local physicians to develop investigator initiated and applied research projects. Processed trials for compassionate use of drugs. Show less

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  Mms

  Jan 2015 - Jan 2017

  Project manager

  • Directed clinical research projects for Fortune 500 pharmaceutical companies. • Responsibilities include defining project objectives, deliverables, roles & responsibilities, project plans and budgets. Single point of accountability (SPA) for all client communication. • Developed, negotiated and awarded contracts with leading pharmaceutical for clinical research conduct standard operating procedures. Project deployed global staff of 10 and completed on time and 15% under budget. • Managed existing order book and grew business by responding to Request for Proposals. Show less

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  Karmanos cancer institute

  Jan 2017 - Jan 2019

  Phase i clinical trials manager

  • Responsible for business development of the phase I clinical trials including monitoringquality metrics, tracking clinical trial portfolio and managing feasibility reviews for studies.• Connecting with global pharmaceutical sponsors to bring in new clinical trials.• Developing and organizing pipeline meetings for Karmanos Cancer Institute (KCI).• Day to day management of phase I clinical trial staff, evaluate staff performance with inputfrom Medical Director of Phase I program.• Interfacing, coordinating and collaborating with IRB, central data management services andthe clinical staff. Ensuring Clinical research study conduct is performed in compliance to GCP and FDA regulations and guidelines. Show less

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  Iqvia

  Jan 2019 - now

  Senior clinical project manager

  • Managed regional and global projects and team leadership of 15 full time staff. Successfully delivered clinical research projects worth nearly $50MM.• Negotiated with clients to assure IQVIA Biotech operational processes are maintained and projects are done within budget and on time• Reviewed and identified project study trends and proactively respond to client and respective team member’s needs.• Developed appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzed information and developed innovative solutions to challenges• Identified, defined, documented training requirements in LMS systems and assured project level compliance with study specific training requirements. Responsible for change management on all assigned projects.• Assured projects assigned are run according to SOPs and WP as refined in the contract.• In conjunction with management, assisted with developing, documenting, and updating internal processes and procedures required for consistency across programs such as SOPs, working practices, and related quality assurance forms.• Assisted in the development and delivery of capability and proposal defense presentations to prospective clients. Supported Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represented senior management in negotiation of contracts as appropriate.• Participated in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually. Maintain current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.• Responsible for maintaining personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff. Show less