Simone Stephenson, Pmp Email and Phone Number

•Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program•Serve as key client contact for assigned projects and responsible for appropriate issue escalation to CAIR program and/or stakeholder(s)•Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working; escalate risks newly identified by the project team to stakeholders•Leads core project team and facilitate team’s ability to lead extended/complete project team•Line manage Project Managers, Senior Project Managers and Associate Project Managers for training, utilization, development and performance review •Partner with Financial Analyst to report revenue and milestone projections through study completion •Proactively identify out of scope activities, execute necessary change orders and support negotiations with client on project budget issues

•Responsible for operational conduct of global projects for multiple clients, according to Covance Standard Operating Procedures, ICH Guidelines and GCP with total responsibility for revenues of over $5M annually•Managed and tracked study budget of over $50M including out of scope activities or new activities as requested by the client •Provided and tracked monthly to quarterly spend versus milestone achievements to ensure financial health to manage scope creep and overspend•Managed multiple vendors regarding specifications and study start up activities, auditing budgets and monitoring changes from initial proposal and summarize for upper management•Served as Senior Project Manager for Oncology project indications with activities inclusive of study start up including feasibility, review of site selection questionnaires and compiling lists of sites in North America, South America, Europe and Asia-Pacific countries

•Accountable for the writing of concept sheets, clinical protocols( Phase IIIb), amendments, ICFs and all other study related documents in collaboration with the Global Program Medical Director, Program Section Lead and Medical Scientific Expert•Created operational trial timeline along with line function support ensuring that all deliverables are met within budget and on time with quality•Worked with Clinical Operations Manager to manage trial allocation, resource allocation and country development such as creating feasibility tools for country participation, writing monitoring plans and all other data capture tools including but not limited to CRFs, protocol deviation list, questionnaires, diaries, translations and edit checks•Planned and drove multi-national investigators meetings and lead protocol training meetings for 40 international thought leaders•Presented at internal board meetings to defend study rationale and secure trial funding utilizing bench markings and risk mitigation strategies•Lead and matrix managed the global multidisciplinary Clinical Trial Team(CTT) with over 5 line function representatives to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures•Responsible for the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs vendors. •Accountable for vendor selection, management of vendor start up, oversight of vendor activities and interaction during trial conduct and report and assess on vendor performance during the trial•Developed, managed and tracked the trial budget of over $30M as well as ensure accuracy of trial information in all trial databases and tracking systems•Independently managed the day-to-day activities of 3 study assigned Clinical Managers contributing to talent and career development and providing input to performance evaluations and promotion recommendations

•Serves as the clinical trial leader for Phase IV Novartis sponsored oncology studies and COOP group studies, ensuring that the trials are conducted per protocol•Collaborates with the medical director to develop study concept, write clinical study protocols, informed consents and amendments as required•Develops individual site budget with guideline ranges for contract/budget negotiations •Performs all activities in collaboration with data management and biostatistics required for clinical database lock •Responsible for writing of the clinical study report(CSR) and subsequent publication of manuscript to major Oncology journals•Interacts with key departments, external vendors, central labs, site investigators and coordinators fielding study related questions to ensure proper study conduct•Conducts kickoff meeting in collaboration with CROs as well as perform SIV during study start up•Performs weekly teleconference with clinical team to report on progress of the study

•Responsible for independently drafting, editing, reviewing and negotiating all Clinical Trials Agreements, Work Orders, budgets and amendments•Served as a liaison with the Legal and Risk Management Departments in the contracting process as well as for reviews to Informed Consent Forms from IRBs•Managed and trained all CROs when utilized for negotiating global full service contracts on Roche’s behalf•Worked with Attorneys and executives of third party companies in finalizing all US investigator site contracts •Processed and executed all contracts, once negotiations are complete and advice study management teams of when to proceed with study start up procedures•Collaborated with internal and external global alliance leaders to ensure that established contracts and outsourcing processes are in place to deliver high quality performance.

•Performed discrepancy management and resolution for assigned centers in a global multi-center Oncology Clinical Trial ensuring high quality, complete and consistent data within a projected and specified timeline•Communicated with monitors of assigned centers ensuring that information in resolving queries and collecting data at the site is consistent•Responsible for running validation programs to check for accuracy and completeness of data while maintaining compliance with department SOPs, SMT review plans and project guidelines and standards•Collaborated with Clinical science Team for review of study data (PSS, BRIO) as patients completed the study and data rendered clean for patient and or database closure•Created and utilized various tracking sheets, BRIOS and other data management tools to keep abreast of patient status as well as required timelines for study specific alerts and tasks•Attended the SMT meetings, performed study projects as appropriate