- Responsible for a full range of clinical project management responsibilities including: managing budget, deliverables, and leading cross-functional teams from start up through close out activities according to contracted time, quality and budget parameters - Assigned to manage the full range of clinical projects; from small, limited-scope or single-service projects (such as Data Monitoring Committees), to full service, large scale, complex programs- Accountable for ensuring that all project deliverables meet client and contract expectations, adhering to company standards and processes while maintaining overall client satisfaction- Manage vendor contracts and activities and act as point of contact between vendor and client- Ensure adequate resourcing for functional roles on each team- Develop various project plans to document study team expectations and guidelines- Facilitate project team meetings, including development of meeting agendas, and minutes- Conduct daily, on-going communication via telephone and email, responding to inquiries and client requests- Manage study budget throughout the duration of the project, including identifying out of scope activities- Manage Trial Master Files (TMF/eTMF)- Produce periodic reports, e.g. budget health, executive summary reports, training compliance

- Supported project team members and client representatives to assist in the timely initiation, conduct, and completion of clinical trials- Provided administrative support to Project Managers and Project teams- Drafted various project plans (Project Management Plan, Monitoring Plan, TMF Plan, Communication Plan) as well as created Change in Scope documents for PM review and approval- Developed and distributed Investigator Notifications for Expedited Safety Reports- Prepared audit responses on behalf of the Project Manager - Maintained weekly and monthly reports in client interface portal- Coordinated project team meetings, including development of meeting agendas and minutes- Assisted with management of project eTMF: Reviewed, uploaded and reconciled trial and country level documents. Provided input on TMF Index- Clinical site end-user set-up for vendor system access- Maintained up-to-date project team and vendors lists

- Provided administrative and budget support for Study Delivery Leads (SDLs) and Project Delivery Leads (PDLs) for GSK Vaccines projects under a Functional Service Provider model- Ensured high quality and up-to-date information in planning and tracking tools for project and study level data (e.g. SAP, eTrack, MS Project, Planisware) - Ensured consistency of the information for agreed study and project level information between the Clinical Project Tracking and other relevant databases using available reports - Compiled data in preparation for study/project presentations and updates related to time, budget, quality- Coordinated Study Budget Breakdown (SBB) process and tracked SBB status from initiation to approval, including encoding SBB into tracking system, and ensured consistency between tracking system and Intercompany Clinical Trial Agreements (ICTAs) - Reviewed Budget Actuals vs. Forecasts, monitored expenses (invoices and cross-charges) on a regular basis- Participated in monthly budget review meeting preparation and cost management plan maintenance - Resolved deviations/issues in actual expenses and escalated if required to SDL/PDL - Contributed to contract development (ICTAs, Service Agreements) - Supported SDL and PDL for quality assessment/controls and inspections/audits as required (including providing support to TMF completeness and quality assessment) - Supported the SDL/PDL for study and project coordination (e.g. providing the team with study-related reports, actions follow up, etc.)- Collected central study essential documents, conducted Level 1 QC audits, and kept an overview of local study essential documents- Participated in study specific meetings (including preparation of meeting agendas and minutes, action items follow-up with team members, and archiving) - Championed process improvements - Interacted with other team members to share best practices, lessons learned and implementation of improvements

- Actively participated on matrix teams supporting new diabetes asset for product launch: Copy Approval, Medical Matrix, Risk Evaluations and Mitigations Strategy (REMS)- Performed document reviews to ensure that training and promotional materials were appropriate for target audience, clinically relevant, and medically accurate- Reviewed and approved 165 pieces totaling over 6,000 pages of material in 2014 which allowed for on-time training of sales force and successful launch of new diabetes product to the market - Managed project timelines of vendor to facilitate completion of deliverables on time and within budget- Developed and edited Data on File communications used in response to healthcare provider inquiries

- Provided timely and accurate delivery of clinical modules for New Drug Application (NDA) annual reports and Developmental Safety Update Reports (DSUR) to ensure compliance with company’s regulatory requirements from the FDA- Achieved 100% on-time delivery of clinical sections of NDA annual reports and DSURs for 5 products over 5 years- Verified study data and evaluated bibliography search criteria - Developed relationships within various functional areas and Local Operating Companies globally to facilitate effective collaboration for reporting of data - Coordinated virtual Global Investigator meeting to facilitate reporting of final study data to participating investigators

- Proactively managed operational support for large Investigator Sponsored Studies (ISS) program- up to 76 active studies (pre-clinical through phase IV development) from start-up, contracts and maintenance through final study reporting- Analyzed and managed project budget variances to a target of 3% or less by efficiently forecasting budget and processing investigator grant payments- Effectively highlighted non-performing sites facilitating swift action to remedy issues- Tracked and reported monthly study metrics as well as Adverse Events (AE) and Serious Adverse Events (SAEs)- Performed activities as certified Local Expert for various study tracking systems - Represented department on process improvement teams as Subject Matter Expert (SME) and Operations Advisor- Participated in User Acceptance Testing (UAT) to develop new database for ISS program- Assisted in development of new global SOP by participating as SME on review team- Trained and mentored colleagues to ensure consistent communication of best practices resulting in improved productivity and positive team atmosphere- Maintained investigator-sponsor’s regulatory, legal, and financial files per SOP- Liaised regularly with functional team members and investigative site staff- Recommended process improvements and partnered with matrix team members to enhance quality and timeliness of study delivery- Promoted effective change management across diverse staff

- Provided administrative support for clinical development team: arranged travel, coordinated team meetings, produced and submitted expense reports and check requests, processed vendor invoices for payment- Coordinated Independent Data Monitoring Committee (IDMC) including contracts, meeting logistics and maintaining confidential subject data files - Facilitated execution of Consulting Agreements and Confidential Disclosure Agreements - Estimated and tracked group travel spend providing monthly metrics - Functioned as Database Custodian for department managing access requests for shared areas