Ursula Simms Email & Phone Number

Munich Area, Germany

Successfully led several opportunities and large global teams which culminated in preferred provider awards and awards of large programs.

Munich Area, Germany

Directed the delivery of clinical development proposals and related client deliverables within time and quality requirements including development of win strategies in conjunction with assigned team. Scope of support includes all therapeutic areas and regions. Critical assessment of all opportunities allocated to the team and appropriate decision-making regarding the assignment of opportunities within the division or to other functional areas. Overall responsibility for initiating and… Show more Directed the delivery of clinical development proposals and related client deliverables within time and quality requirements including development of win strategies in conjunction with assigned team. Scope of support includes all therapeutic areas and regions. Critical assessment of all opportunities allocated to the team and appropriate decision-making regarding the assignment of opportunities within the division or to other functional areas. Overall responsibility for initiating and leading change initiatives within the division and worked with peers and executives as necessary with the division and across the company to achieve objectives.Responsible for client facing activities to assess opportunities and/or convey strategy in the absence of or in addition to functional area attendance.Responsible for setting delivery strategy for large projects or a program of projects, (in excess of US$ 25 million) and those opportunities deemed significant relative to corporate goals and development strategy.Responsible for coordination of all proposal development activities for an alliance account.Provided support to project teams at bid defense meetings.Supervision, support, training and mentoring to Associate Directors, Senior Managers and/or Managers. Spearheaded development of robust historical study start-up metrics through web-based dashboard to enable data-driven projections for proposals.Developed automated enrollment projection tool based on country-specific start-up metrics Show less

Munich Area, Germany

Management and mentorship support for Project Managers assigned to franchise projects.Contributed to optimising company project management techniques to achieve operational excellence, timely and quality deliverables, sponsor’s contractual expectations and satisfaction, target profitability. Member of key client Joint Operating CommitteeDay to day responsibilities:- Lead role in the development of proposal strategies and budgets, bid defense meetings, contractual… Show more Management and mentorship support for Project Managers assigned to franchise projects.Contributed to optimising company project management techniques to achieve operational excellence, timely and quality deliverables, sponsor’s contractual expectations and satisfaction, target profitability. Member of key client Joint Operating CommitteeDay to day responsibilities:- Lead role in the development of proposal strategies and budgets, bid defense meetings, contractual finalisation.- Executive point of contact for sponsors in assigned franchises.- Overseeing and directing of global and pan European projects, focusing on progress metrics and contractual deliverables, in all service areas- Proactive risk identification and management plan focusing on timelines, quality, costs.- Day to day supervision, mentoring and motivation of PPD Project Managers and cross-functional teams in assigned projects.- Attendance and strategic input in key project meetings including Project Planning Meeting, Kick-off Meeting, Global Risk Management Meetings.- Continuous review of project resources issues and monthly validation of resources plan.- Lead role in revenue and cost management and profitability, from initial proposal through to contract finalization and contract modification process Show less

Munich Area, Germany

• Successfully managed several global Phase II and III oncology studies in complex contractual settings (i.e., two sponsors, and sponsor/collaborative group) and large multifunctional project teams.• Successfully managed conversion of an investigator-initiated oncology study to a registration study, culminating in the approval of a blockbuster compound.• Effectively managed a Phase II program in Asthma including managing external vendors and sponsor team members • Led project… Show more • Successfully managed several global Phase II and III oncology studies in complex contractual settings (i.e., two sponsors, and sponsor/collaborative group) and large multifunctional project teams.• Successfully managed conversion of an investigator-initiated oncology study to a registration study, culminating in the approval of a blockbuster compound.• Effectively managed a Phase II program in Asthma including managing external vendors and sponsor team members • Led project kick-off meeting• Prepared and executed presentation of project specific and therapeutic training to clinical project teams.• Proactively managed study budgets.• Participated in project team and executive review meetings to communicate progress of studies, quality issues, budgetary issues, and operational concerns.• Adept at orchestrating internal and external project team meetings that were inclusive of representatives of PPD clinical, data management, biostatistics and medical writing personnel as well as personnel from external vendors.• Presentations at large international investigator meetings (>200 delegates).• Significantly contributed to several PPD internal endeavours for process and systems improvement and implementation by developing and implementing tools and processes across departments. Show less

Munich Area, Germany

• Developed and implemented concepts and tools to facilitate planning and tracking of clinical trial projects, as well as reconciling project tracking information between operational departments, Finance and Business Development. • Improved processes and developed global Project Management Standard Operating Procedures as a member of an international team. • Trained and supported Project Managers in project planning and tracking tools, as well as the more conceptual aspects of Project… Show more • Developed and implemented concepts and tools to facilitate planning and tracking of clinical trial projects, as well as reconciling project tracking information between operational departments, Finance and Business Development. • Improved processes and developed global Project Management Standard Operating Procedures as a member of an international team. • Trained and supported Project Managers in project planning and tracking tools, as well as the more conceptual aspects of Project Management. • Facilitated project accounting, identifying deviations in project scope and negotiations with clients. Developed proposals for clinical research projects. • Contributed to the development and delivery of a seminar on Project Management of Clinical Trials. • Managed the development and European-wide implementation of a management information system for planning/ tracking clinical research project budgets and metrics, including conceptualisation, project and budget planning, business process mapping, managing an international multidisciplinary project team, developing and delivering training on the system. Show less

Munich Area, Germany

• Successfully managed a global retrospective clinical research project in non-Hodgkin’s lymphoma, involving 4 clinical trials in Germany, the UK and the USA including planning and implementing appropriate procedures for project conduct in conjunction with the sponsor company, and directing a multinational, multifunctional team. • Ensured adherence to study timelines, quality standards, resourcing and budget. • Identified deviations of scope in the project and negotiated appropriate… Show more • Successfully managed a global retrospective clinical research project in non-Hodgkin’s lymphoma, involving 4 clinical trials in Germany, the UK and the USA including planning and implementing appropriate procedures for project conduct in conjunction with the sponsor company, and directing a multinational, multifunctional team. • Ensured adherence to study timelines, quality standards, resourcing and budget. • Identified deviations of scope in the project and negotiated appropriate contract amendments with the sponsor company. • Project culminated in a preferred provider agreement between the CRO and the sponsor company for projects with a high level of complexity. Show less

Munich Area, Germany

• Developed proposals for national and international clinical research projects within specified timelines and co-ordinated review and input from appropriate operational and senior business development staff. • Presented proposals to sponsor companies during bid defense meetings.• Researched and analysed sponsor company background as part of the large account management process and assisted in developing strategies for business development activities. • In conjunction with Project… Show more • Developed proposals for national and international clinical research projects within specified timelines and co-ordinated review and input from appropriate operational and senior business development staff. • Presented proposals to sponsor companies during bid defense meetings.• Researched and analysed sponsor company background as part of the large account management process and assisted in developing strategies for business development activities. • In conjunction with Project Managers, prepared and negotiated contract amendments with sponsor companies. Show less

Munich Area, Germany

• Successfully managed start-up and monitoring of study sites in Germany for several national and international Phase III and IV clinical trials in the anti-infectives therapeutic unit including tonsillitis, respiratory tract infections, post-operative prophylaxis.• Planned and participated in several national and international investigators’ meetings. • Participated in protocol and case report form development.• Ensured critical documents were complete and correct before… Show more • Successfully managed start-up and monitoring of study sites in Germany for several national and international Phase III and IV clinical trials in the anti-infectives therapeutic unit including tonsillitis, respiratory tract infections, post-operative prophylaxis.• Planned and participated in several national and international investigators’ meetings. • Participated in protocol and case report form development.• Ensured critical documents were complete and correct before initiation of study sites. • Prepared monthly enrollment updates and maintained study tracking system. • Interfaced with Accounting Department to ensure timely payments of investigator fees. • Maintained study files. • Assisted in the preparation of abstracts, poster presentations and publications. Show less

Jeddah, Saudi Arabia

• Successfully developed and implemented a computerised payroll system using a relational database system.• Successfully developed and maintained spreadsheets for compiling monthly statistical data for various hospital departments. • Compiled minutes at departmental meetings and meetings of the Medical Board. • Assisted members of the Faculty of Medicine in the preparation of abstracts and publications

Jeddah, Saudi Arabia

• Managed nursing department resources to ensure adequate staffing levels in all hospital units and daily shift allocations. • Compiled departmental statistics/performance metrics. • Maintained nursing department personnel files

Diploma In Computer Sciences, Computer And Information Sciences, General

Linguist Diploma, English Language And Literature, French