Experience

Santhera Pharmaceuticals

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project and Planning Manager

  • Apr 2017 - Present

  Implemented and manage a full project management system in Clinical Development to meet requirements for cross functional project teams. Set up Portfolios, Programs and Projects across therapeutic areas to track and report on the progress of development programs against agreed targets and identify issues and produce mitigation plans to facilitate decision making.• Established project and resource planning and finance tool(s) meeting both the project management and financial budgeting and tracking requirements of the development organization and its reporting obligations to corporate finance• Established critical path activities and milestones in project plans and clinical development programs• Work with all functions within clinical development to establish clinical program/study plans, timelines and budgetary requirements and track spending and accruals against budgets• Provide updated plans and tracking cross functionally for projects and programs.• Work closely with accounting and corporate finance to provide all information demanded for planning and tracking purposes• Ensure real-time updates to project plans, timelines and budgets and report as required• Provide relevant and timely reports to executive management on all aspects of clinical development projects.



Novartis Oncology

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Clinical Trial Budget Manager

  • Apr 2015 - Mar 2017

  Managing budgetary requirements for complex oncology clinical programs by generating consolidated estimates on current budget and yearly forecasting. Identify issues and produce mitigation plans to facilitate decision making.Budget responsibilities:• Responsible for the creation, approval and maintenance of well-developed, trial budgets adhering to organisational financial compliance guidelines.• Leading yearly review of study lifetime cost estimates in the management alignment cycles, providing clear budgetary requirements, cost saving potential scenarios highlighting financial and operational risk. • Providing monthly rolling forecast to management for all clinical studies within allocated projects.• Driving generation of grant plans and total trial grants with clear understanding of key clinical study design, vendor and organisational requirements.• Accountable for ensuring adequate support for all aspects of clinical trials budget including timely funding to avoid delay in trial execution. Proactive in resolving issues impacting budget management at the team or study level.Stakeholder management and engagement:• Initiating resource review meetings to challenge and track program/trial timelines, resource requirements and expenditures and initiate adjustments as needed.• Mentoring and providing training for new Budget Managers and clinical trial teams on best practice development of trial budget and operational strategy, and on securing financial approvals.• Providing input to the development of process standards, budgetary tools and performance metrics to achieve excellence in Global Oncology Clinical development and Medical affairs. Driving implementation to achieve faster more effective cooperation with key internal and external stake holders.

• Clinical Trial Budget Manager

  • May 2013 - Mar 2015

  Responsible for the budget of 3 clinical programs:- Manage and ensure financial compliance for over 30 clinical studies, Provide a link between management and the clinical teams for budget related aspects of the trials.- Work within the Project Financial Team to ensure all project related finance issues are addressed early to minimise delays and resolve issues. Provide budget related clinical information to the team and feedback to the clinical trials teams for any budget related issues.- Identify issues and propose mitigating plans for facilitating decision making. - Responsible for timely and accurate preparation, approval, tracking and management of each trial’s lifetime budget.- Maintain accuracy and completeness of the external budget for these programs in the resources management system (OPX2 / Planisware)- Challenge and track program/trial timelines, resource requirements and expenditures and initiate adjustments as needed.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Lead

  • Apr 2012 - May 2013

  Responsible for the Data Management aspects of multiple trials within the project.- Ensured all trials complied with the global standards, maintained data integrity within the trials.- Managed the DM vendor relationship to ensure timely and accurate data was delivered for all trials.- Ensured Data Management was standardized within the project, worked within the Clinical Team to provide all Data Management related information from start up to database lock. Responsible for the Data Management aspects of multiple trials within the project.- Ensured all trials complied with the global standards, maintained data integrity within the trials.- Managed the DM vendor relationship to ensure timely and accurate data was delivered for all trials.- Ensured Data Management was standardized within the project, worked within the Clinical Team to provide all Data Management related information from start up to database lock.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Data Manager

  • Apr 2010 - 2012

  In addition to standard Data Management Duties I was responsible for ensuring consistency of Protocols, VAPs & CRFs, data transfer specs, etc. for all trials within assigned project. I also acted as Project Data Manager for multiple smaller projects providing professional Data Management input to the Internal Clinical Teams and contributing to the generation of protocols. As a Lead I was responsible for supporting and mentoring Assistant Data Managers (ADMs) and Trial Data Managers (TDMs) for allocated trials within assigned project(s) and ensuring adherence to process and project timelines.



Hoffmann-La Roche

• DM

  • Dec 2008 - Apr 2010

  I was involved in Data Management for two adaptive design phase I / phase II oncology studies which involves challenges with changing databases and schedules, UAT testing and edit check adaptation. While working as a data manager I was also responsible for Local and Central Laboratory data cleaning and reconciliation. This involves working closely with Clinical programming, Lab loading specialists, Monitors, Scientists and Operations as well as other Data Management personnel on similar studies to ensure a standard approach is adopted to dealing with received Data.



AstraZeneca

• Study Delivery Operations Specialist

  • Mar 2008 - Oct 2008

  I was responsible for managing DM processes during an outsourcing program and keeping the Study Team and the vendor informed of any updates made during the transfer process. This involved creating training documents and supplying training sessions to familiarise the vendor with AZ specific systems. I was responsible for the creation and delivery of DM presentations, creation, updating and transferring both the DM documentation and DM activities to the vendor. Providing test data and performing a quality review of data and queries to ensure AZ standards and SOP’s were being followed.



PPD

• United States
• Research Services
• 700 & Above Employee

• CDA

  • Jan 2005 - Mar 2008

  Working on phase III studies, Support the set up of study activities such as CRF design, database design, including testing of data entry screens, and Data Validation Manual (DVM) creation. Perform quality control activities as defined in the DVM and ensures all necessary documentation is created and filed correctly. Support the training team as a Subject Matter Expert in the scanning process and as an assessment reviewer. Delegate DPT tasks within the study team. Train DPT’s on study specific matters, Perform competency reviews and training.