I am the Clinical Innovation Director at Volv Global SA based in Lausanne, an applied data science company, that creates cutting edge approaches to solving difficult problems in healthcare and life sciences.

Reimagining clinical research by bringing together patients, healthcare professionals and the clinical research teams developing new treatment options for them. Putting patients at the centre using Real World Patient Data to optimise clinical development study protocols. Using Real World Patient Data to make study feasibility, site- and patient enrolement significantly more efficient, cost effective and quicker. Accelerating the overall clinical development time and bringing promising new treatment options to patients quicker.

Business Process Owner for the “Clinical Monitoring Process”• Responsible for newly defining business process around (risk based) clinical study monitoring to enable better outsourcing specification, improved sponsor oversight of outsourced clinical monitoring activities and increased flexibility around the operating model for clinical study monitoring.Functional Excellence Leadership to improve sponsor oversight of fully outsourced clinical development studies and enhance sponsor relationship with study sites.• Alignment, optimization, global standardisation and implementation of sponsor oversight of outsources site monitoring activities and sponsor site relationship.• Conduct and/or oversee the identification, development, training, implementation and communication of process, practices and standards to advance the Site relationship & Operations Lead (SROL) function globally.

Strategic & operational consultancy services in planning, optimising and delivery of Clinical Studies & Programs. Activities include but are not limited to:• Operational strategy input to Clinical Development Plan, Protocol Development and Strategic Outsourcing Partnership; planning & oversight for set up of a number of first-in-patient studies in three auto-immune indications. Planning, preparation and conduct of KOL Advisory Boards. (Biotech start-up company, Belgium)• Deliver strategic & operational consultancy services to optimize the delivery of Clinical Study Programs by positively impacting enrolment & retention of patients into clinical studies (Collaboration with a UK based Strategic Marketing & Medical Communications Firm, working mostly with Swiss based clients)• Supporting an organisation change project in Regional Study Management function which involved re-writing job descriptions (Midsized Farma).• Lead the creation of a cross-company & cross-functional Focus Group (non-commercial initiative).

Role combining functional leadership responsibilities as line manager in Global Clinical Operations with clinical program oversight responsibilities as Clinical Operations representative on a Global Clinical Development Team• Lead AD ClinOps for Lymphoma Clinical Development program; Providing Clinical Operations expert input from early planning through study conduct for a program of clinical studies; Overseeing clinical operations personnel globally and enabling cross functional study teams to ensure delivery of Lymphoma drug development program / studies to time, quality and budget; Providing therapeutic and study input and guidance• Line manager in Global Clinical Operations; directly line manage staff in Clinical Operations; leading, coaching and guiding clinical operations personnel and managing their overall performance; contributing to the development and implementation of departmental strategy; managing budget and resources• Bringing innovative approaches to conduct of clinical studies & programsKey achievements include:- Developed and implemented novel and highly cross functional strategies and approaches towards investigator site engagement, training and communication to improve recruitment and retention into clinical trials- Developed and lead the implementation of leadership development program for senior study management staff- Championed “early engagement” of CRO partners in planning and preparation for new clinical studies within fully outsourced partnership model

Organisational consulting and clinical operations contracting role. Supporting client organisations in delivering business critical projects - such as Organisational Change Initiatives, Clinical Studies and Drug Development Programs through:• Enquiry: get insight in current status and thinking & client desired outcomes through appreciative enquiry and interviewing (i.e. revealing the true roadblocks that delay the project)• Design: design & plan the approach to meet client desired outcomes (i.e. workshops & coaching sessions to bring a project back on track)• Delivery: facilitate the desired change or turnaround that enables successful delivery of business critical project through running workshops, performing one-to-one coaching, bringing leadership capability, project management skills and change management principles, and developing these capabilities in the client organisationKey achievements include:- Lead major functional improvement taskforce with 4 different work streams for a pharmaceutical client amidst their reorganisation of the clinical development functions- Co-developed and delivered (facilitated) a series of strategic intervention meetings to re-engage, motivate and focus a global team responsible for the delivery of a program of studies for a large pharmaceutical clientCritical Business Solutions is a group of consultants with a unique blend of knowledge, insight and skill set. Our talent is in providing an environment that enables smart people to have authentic and powerful discussion that lead to new action, fresh perceptions and extraordinary results.We primarily focus on the medical and pharmaceutical sector, as well as energy, environmental and high-tech industries.For more information about Critical Business Solutions see our website www.CriticalBusinessSolutions.com

Functional Leadership role in Study Management; Functional leader and line manager in Study Management department• Managing performance and supporting personal and professional development of permanent and contract staff in Study Management Department; contributing to the development and implementation of functional strategy and running of departmental operations; providing input and drive the implementation of change initiatives & process improvements with the objective of enhancing productivity and efficiency and maintaining globally consistent processes• Responsible for developing new sourcing strategy for new hires (temp & perm); establishing a network of preferred external service providers for recruitment & selection and managing these partnerships; recruiting and selecting permanent and contract staff into the Study Management Department; collaborating with the local resourcing manager and functional management team to ensure that sufficient, appropriately qualified, resources are identified, made available and allocated to studiesKey achievements include:- Developed new flexible sourcing strategy for temporary study management staff, rationalising the number of vendors involved, increasing efficiency and responsiveness to flexible sourcing needs and improving spend transparency

Drug Development Project aligned Functional Leadership role; Functional leader and line manager in the Study Delivery Department• Manage performance and support personal and professional development of permanent and contract staff in Study Delivery Department; contribute to running departmental operations and strategy• Provide expert input, support and advice to enable the delivery of a global clinical study program in Oncology; • Manage organisational change; Contribute to the development and implementation of new ways of working• Key member of Resource Team challenged to provide solutions for Project and Departmental resource issuesKey achievements include:- Initiated and facilitated a series of strategic interventions influencing organisational climate & leadership styles that optimised the dynamics between Clinical Development Team and operational Study Teams within a large clinical development program- Facilitated integration of study management and data management functions at the level of individual contributors under a new operating model- Developed and maintained departmental resource tracking tool supporting the project allocation and resource planning / hiring activities

Cross functional team leader role; Leading a global cross-functional delivery team responsible for delivery of an Oncology Phase III Clinical FDA Regulatory Commitment Study to time, quality and budget.• Key contributor to contract negotiations and alliance with external vendors and participating Marketing Companies; Built strong relationships with external vendors and participating Marketing Companies across a number of countries in Europe, South America and Africa and managed their contribution; Built extensive experience with Patient Reported Outcomes (PRO) and e-PRO solutions

Operational study management role; Responsible for day-to-day management and coordination of operational activities supporting the delivery of global Phase III Clinical Studies in Oncology• Core member of cross-functional delivery team; Point contact for local clinical project leaders and study monitors in participating Marketing Companies as well as CRO vendor project managers

Operational study management role; Responsible for the delivery to time, quality and budget of the Dutch Marketing Company contribution to clinical studies in a global Cardiovascular (hyperlipidaemia) phase II and III trial program• Responsible for feasibility testing, selecting study centres, preparation & management of study budgets, initiation, monitoring, management and study closure• Responsible for training & supervising new monitors (junior members of staff); • Build and maintain relationships with KOLs and investigators

Clinical Trial Management & Monitoring; Responsible for daily management and coordination of the Dutch Marketing Company contribution to clinical studies that are part of a global phase III / IV development programs in Neurology (migraine), Psychiatry (schizophrenia) and Anaesthesia (TCI)• Investigator selection, study preparation, initiation, monitoring, management, investigator payments and study closure; Coordination of clinical study supplies for all studies executed in The Netherlands (between June 1999 and October 1999)

Clinical Trial Monitoring; Responsible for monitoring and coordination in the Netherlands of global Phase IIIb and IV Cardiovascular studies (heart failure and hypertension); Responsible for quality control checking of clinical study dataClinical Trial monitoring activities (outplacement to Zeneca) / In house CRA / data review activities (IMRO)