Expertise in the conduct of phase I-IVclinical trials including the design, initiation, overall progress and reporting Mentor/coach for young professionals in clinical research, leadership and communication skills Line manager Specialties: Clinical Development Project management Leadership skills Coaching skills Communication skills

Senior Health and Nutrition Claim Manager (EFSA) @ Support the ELN Division in implementing a global health and nutrition strategy. Support the ELN Division in implementing a global health and nutrition strategy. Drive implementation of clinical research programs to maintain a superior innovation pipeline taking the EU legislative requirements into account. Identify and evaluate risks and opportuntities for health claims. Lead the team to deliver the totality of scientific evidence by collecting and analyzing data from internal and external databases/publications to establish health and nutrition claim submissions according to EU legislation to maximise the health impact and commercial opportunities for infant and toddlers products. Liaison between the business & regulatory & public affairs & scientists From April 2015 to Present (9 months) Utrecht Area, NetherlandsGroup Leader / Director Clinical Studies Group Baby Nutrition @ Leading Baby Nutrition team in the Clinical Studies Platform. Responsible to facilitate the work as delivered by the CS Team leaders and CS Managers/Researchers, and to manage and align with stakeholders within the CS Platform as well as the Baby Nutrition Division. To translate the mission and strategy of the CS Platform into actions for the Division or team and to shape the future of the team in close cooperation with the CS Team leaders. Evaluate performance and cooperation with the Division and CS Team leaders, and lead improvement processes.Build on the future of the Divisional team, and the CS Platform as a whole Set priorities within the Divisional teamProvide input to the QS Manager on the maintenance and continual improvement of the Quality management system Ambassador of the Danone Leadership College. From July 2013 to Present (2 years 6 months) Ambassador/Facilitator of the Danone Leadership College @ The Danone Leadership College is to develop a distinctive leadership culture within all Danone colleagues. The aim is to develop the leadership of all Danoners, in order to generate both business outcomes, and contribute to people growth, through superior engagement, empowerment & development. From June 2012 to Present (3 years 7 months) Utrecht Area, NetherlandsTeam Leader Brain and Immunity - Clinical Studies Platform @ Ambassador of the Danone Leadership College. The Danone Leadership College is to develop a distinctive leadership culture within all Danone colleagues. The aim is to develop the leadership of all Danoners, in order to generate both business outcomes, and contribute to people growth, through superior engagement, empowerment & development. Line manager of a team of Clinical Study Managers and Clinical Study researchers in order to jointly deliver credible scientific evidence for health benefits of Danone's products. •Act as primary contact for the internal sponsor of the clinical studies conducted •Manage timelines, resources, and quality of the clinical studies conducted •Portfolio management •Ensure study set up and conduct is in accordance with Good Clinical Practice •Conduct and guide in the conduct of clinical trials, e.g.: develop and review study protocols, study documents including CRF, provide input into the protocol development process and study analyses phases, select investigators and third parties, coordinate the process of data management and statistical analyses, write and review study reports and scientific publications. From January 2012 to June 2013 (1 year 6 months) Global Trial Manager @ To coordinate the conduct of phase II-IVclinical trials (with a focus on emerging markets) including the initiation and overall progress of these trials. To coordinate and execute all (logistical) activities in the preparation/submission, execution and datamanagement/analysis phase of international trials. To be responsible for the set up of and adherence to study budget and the set up of and adherence to study timelines. Line management responsibilities for a group of Trial Managers and Trial Specialists. Provide advice, share knowledge and experiences, and teach colleagues using a self-discovery approach. Act as a sounding board, direct a person to some end result, strategically assess and monitor the progress and give advice for effectiveness and efficiency. Conduct weekly routine meetings to address trial related tasks, progress of training, knowledge on the indication area, etc. Conduct job interviews, set objectives and targets, guide personal development plans, job appraisals. From January 2010 to January 2012 (2 years 1 month) Clinical Study Manager @ To coordinate the conduct of phase II-IVclinical trials in medical nutrition including the design, initiation and overall progress of these trials. To coordinate and manage all aspects of protocol development including the soliciting of internal and external advice. To provide clinical-scientific expertise for the preparation of protocols and documents for regulatory purpose.To coordinate and execute all (logistical) activities in the preparation/submission, execution and datamanagement/analysis phase of international trials. To be responsible for the set up of and adherence to study timelines. From February 2011 to May 2011 (4 months) Trainer @ Provide training on ICH-GCP, European Clinical Trial Directive, USA Code of Federal Regulation-part 21, Clinical Development including all CRA related activites. Provide advice, share knowledge and experiences. From October 2010 to January 2011 (4 months) Global Clinical Project Manager @ To coordinate the conduct of phase II-IVclinical trials in women’s Health including the initiation and overall progress of these trials. To coordinate and execute all (logistical) activities in the preparation/submission, execution and datamanagement/analysis phase of international trials. To be responsible for the set up of and adherence to study budget and the set up of and adherence to study timelines. From January 2007 to December 2009 (3 years) Clinical Research Scientist @ To coordinate the conduct of phase II-IVclinical trials in fertility and HT including the design, initiation, overall progress and reporting of these trials. To act as the study team leader and be a member of a Global Clinical Development Team.To coordinate and manage all aspects of protocol development including the soliciting of internal and external advice. To provide clinical-scientific expertise for the preparation of protocols, trial reports and documents for regulatory purpose.To coordinate and execute all (logistical) activities in the preparation/submission, execution and datamanagement/analysis phase of international trials. To be responsible for the set up of study budget and the set up of and adherence to study timelines. Team leader of the team responsible for organizing the SOP, WP and GCP related topics training for GCD staff at the annual GCDM From January 2003 to December 2006 (4 years) Clinical Research Associate @ International Clinical Development Team CRA : Act as a contact person for other CRAs involved in the project(s). To have good knowledge of all protocols so as to represent the monitoring organization in the Clinical Development Team. To review and comment on the proposed project deadlines/timelines. To review and comment on the (draft) Clinical Development Plan and Clinical Development Plan updates regarding recruitment strategy and site selection when required. To be responsible for project recruitment strategy. Clinical Trial Team CRA for global phase I-IV trials; To facilitate communication between all involved CRAs and other disciplines such as the Department for Clinical Supply Management and the Department for Clinical Documentation Management. To represent all CRAs involved in the trial on issues such as ICH-GCP, protocol/ CRFs, the feasibility of the trial and the proposed timelines. To agree on the final content of the protocol. To identify functional issues that require a protocol update. To review progress and recruitment problems and take/communicate appropriate actions. To participate in problem solving and where possible contribute suggestions for improvement. To produce and provide the necessary documentation for authorities and ethics committees. To identify function specific issues related to the trial which may impact future or other trials in the project. To review essential trial related trial processes, e.g., data validation directives and drug labelling. To coordinate the input of a CRO or central laboratory so that projects and regulatory requirements are met. To review and update timelines and report delays. To build and maintain an investigator network. To organize and chair investigator meetings. From May 1999 to December 2002 (3 years 8 months) Clinical Research Associate @ Monitoring of a phase III and IV trials Admitting the protocol to Medical Ethical Committees. To negotiate the budget for the trail with the investigator and if applicable with hospital administration. To issue payment requests complying with pending instructions from Finance. To define the time schedule for my part of the trial (from local study preparation through initiation and study close-out) and to ensure that it is met. Conducting Pre-Trial, Trial Initiation Visits and Close Out Visits, Source Data Verification, Monitoring the adherence of the investigator to ICH GCP and other applicable guidelines. From October 1997 to May 1999 (1 year 8 months)

MSc, Medical Biology @ Universiteit Utrecht From 1992 to 1997 Elzendaal college From 1985 to 1992 Ellemieke Von Mauw is skilled in: Clinical Trials, GCP, Clinical Development, ICH-GCP, CRO, Clinical Research, Protocol, Sop, CTMS, Drug Development, Pharmaceutical Industry, Clinical Study Design, Regulatory Submissions, Clinical Monitoring, EDC