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.

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.

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
• Led project kick-off meeting
• Prepared and executed presentation of project specific and therapeutic training to clinical project teams.

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.
• 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
• 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.

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.
• Ensured adherence to study timelines, quality standards, resourcing and budget.
• Identified deviations of scope in the project and negotiated appropriate… Show more
• 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
• 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.
• 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
• Ensured critical documents were complete and correct before initiation of study sites.
• Prepared monthly enrollment updates and maintained study tracking system.

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