Strong, effective, highly motivated manager and team player with proven ability to lead cross functional project teams to deliver quality clinical trial management services, including but not limited to data and on schedule deliverables. Effective communicator and negotiator experienced at managing multiple vendors with competing priorities

Senior Clinical Operations Lead @ Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy. Independently oversees one or more clinical studies by establishing the operational strategy and securing excellence in execution through the CRO partner. From 2013 to Present (2 years) Clinical Project Manager @ Independently manage multiple clinical trials or managea broader range of activities on large multi-center studies. Key Accountabilities: - Responsible for developing and managing approved trial budget(s). - Develop and oversees study operational plan(s). - Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials. - Assist with protocol design and strategy and medical issue resolution. - Participate in study data review and assists with patient narrative writing and other data review activities as assigned. - Contribute significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports. - Proactively identifies project risks and resolves with some supervision. - Participate in the selection of Investigators and vendors. - Mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel. - Represent Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team. From 2011 to 2013 (2 years) Clinical Trial/Project Manager @ Collaborate with cross-functional team to develop and prepare clinical program documentation such as protocols, clinical study reports, submissions, etc. as applicable. Manage protocol development process. Evaluate study protocol for clarity and identify resources required to complete the trial. Plan and execute trial-level project management activities including trial-level timelines, risk assessment, mitigation plans, and other aspects of trial-level project management (e.g. budget, grants, and metrics). Develop and track trial timeline to ensure high quality, and on-time deliverables. Manage and track trial enrollment and trial budget Ensure accurate and timely collection of data and coordination of data locks (final and interim) and site closure. Develop trial level monitoring plan; review and approve monitoring reports. Organized and lead training required by internal and external staff to execute the clinical trial. Supervise appropriate and timely completion of IND and IB updates Track and proactively ensure complete documentation for protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or submission. Partner with Clinical Trial Material Management (CTMM) to ensure availability and proper labeling of study drug. Create drug accountability forms, reconciliation of un-blinding summary, and other study CT material requirements. nteract closely with investigator sites to plan and implement the trial at each site Present training and study information at investigator meetings. Manage site budget and investigator payments. Serve as the central owner of communication across development partners, functional personnel and vendors. Partner with the Clinical Research Physician to present study information at various clinical meetings as needed Lead regular study team meetings. Manage trial in accordance with GCP, ICH and FDA guidelines as well as internal SOPs From 2008 to 2011 (3 years) Senior In-House CRA / Project Management Associate @ Proactively managed vendors as part of global team to execute the largest global project the organization had ever commissioned. Planned and actively participated in the execution of meetings attended by strategic global partners Regularly interacted with global team to procure and ensure delivery of materials and required for project conduct Partnered with the finance team to track and manage project budget Responsible for creation, maintenance and distribution of project specific documents such as newsletters and email blasts Tracked confidentiality agreements, contracts, and performance documents. Partnered with meeting planners to facilitate presentations, breakout sessions and training at Investigator Meetings Performed regular quality checks in tracking databases and ensured timely accurate entry of all required data fields Reviewed all project data in accordance with client guidelines as well as internal SOPs Trained and mentored junior associates Assigned and tracked clear, measurable performance expectations From 2005 to 2008 (3 years) Operations Associate @ Partnered with Project Directors to oversee the conduct of projects and ensured that they began on schedule taking advantage of established efficiencies Developed and maintained project communication tools, operations plans, timelines and work-breakdown structures Procured and maintained materials required for project conduct Generated internal executive project review materials Initiated setup, maintenance, and QC of study tracking databases Facilitated investigator contracts process and ensured timely payment of project related invoices, as appropriate Partnered with finance group to develop project budgets and prepared grant payments based on pre-set timelines and deliverables Interacted with clients and vendors to ensure that project timelines were met and exceeded Partnered with meeting planners to execute investigator meetings Prepared, disseminated, and tracked meeting minutes and action items Acted as integral part of development of departmental SOPs and guidelines, training programs, policies and procedures. From 2000 to 2005 (5 years)

Masters of Science, Strategic Management @ Indiana Wesleyan UniversityB.S, Business Management @ Georgian Court University Hanifah Gordon is skilled in: CRO, Clinical Trials, GCP, Pharmaceutical Industry