Viki Wills Email & Phone Number

Reading, Reading, United Kingdom

Wetherby, England, Gb

Oslo, No

Clinical Trial ManagementLeadershipVendor, Fiscal and Contracts Management

Bergen, Norway, No

o Line Management and leadership of Clinical Ops Teamo Clinical trial budget management o Clinical trial milestone deliveryo Clinical programme management Regulatory interface Oversight GCP complianceo Managing relationships with partner Clinical Research Organisationso Managing relationships with key principal investigators, building on an established network and growing a wider network of key stakeholders.o Playing a key role in the due diligence process when seeking development partnerso Prepare for and lead regulatory inspections

Basking Ridge, Nj, Us

o Accountable for study planning and cross functional execution of oncology studies globally and regionally through CRO selection, management and oversight.o Leadership of site selection & KOL discussions and facilitation of medical writing aspects for study conduct. Management of DSMBs and Steering Committees.o Budget creation and management. Operational metrics determination, review and escalation.o Supervision and development of study managers (permanent, contract and ex-pat).o Development and revision of global processes, systems and functional areas to ensure quality delivery and study integrity.

Boston, Ma, Us

o Oversee all aspects of Clinical Operations in the UK, including having direct managerial responsibilities for career growth, morale, and development of the EU Clinical Operations team.o Represent Clinical Operations on the UK site management leadership team.o Accountable for multi-therapeutic early phase clinical studies utilising scientific knowledge of clinical research.o Cross-functional collaboration with Late-stage and Franchise Leads.o Oversight to ensure appropriate operational/execution strategies, resourcing, timelines, metrics, budget, deliverables, submissions and risk management are optimised for project success.o Key member on the Clinical Development Team and other cross-functional forums.o Driver for process improvement, leading critical process initiatives, defining the role and trial governance of Clinical Operations at Vertex.

Cambridge, Cambs, Gb

o Responsible for ensuring successful execution of clinical and regulatory operations and line management responsibility for the Clinical and Regulatory Affairs teams.o Close collaboration with the Non-Clinical and QA to ensure effective cross-functional delivery.o Close supervision and coaching of the majority of the team as well as key activities and clinical leadership in the progression of several early phase programmes.

o Established consultancy providing international clinical development and clinical operations services including project management, training, process development and implementation, SOP authorship.

Gaithersburg, Maryland, Us

o Lead the Clinical Operations function for Emergent Product Development in US and UK, providing support and expertise to Clinical Project Managers and the associated Clinical, Biometrics and Pharmacovigilance teams.o Oversight of several outsourced clinical research programmes ensuring time, cost and quality compliance in the vaccine and infectious diseases fields in US, Europe, Asia and Africa.o Management of two Clinical Operations Directors and their staff including external consultants.o Define, negotiate and manage clinical study plans and budgets for Emergent product portfolio often in support of external funding opportunities from Government and NGOs (>$10 million).o Ensure internal systems are developed and maintained in compliance with current regulations and audit / inspection readiness.o Identification and liaison with KOLs during clinical development planning activities.o Oversee the selection of and contract negotiation with investigative sites, service providers (CROs) and external contractors to undertake each study.o Ensure that service providers are managed effectively to deliver projects to the highest standard and within time and budget.

Raleigh, North Carolina, Us

o Direct Global Project Support Services across all Kendle locations globally and functions including Project Support helpline and development and maintenance of PMO Portal.o Identify best practices at the project level and standardise across all projects.o Develop global processes, integrate into existing process matrix and support implementation and training. Instigate and execute ‘working smarter’ initiatives across the organisation.o Select and manage Kendle project vendors globally.o Previously held similar roles within Strategic Business Services and Business Support where focus was primarily European and functions included proposal development and defence and financial analysis.

Raleigh, North Carolina, Us

o Oversee day-to-day Project Management operations for the planning, implementation and delivery of all ongoing pan-European and global, full service, cross functional projects in the region for regulatory approval with focus on oncology and CNS.o Serve as functional manager for around 40 project managers, directors and support personnel across UK offices.o Business Development support including budgeting, proposal writing and bid defence for assigned projects and programmes.o Serve as a liaison between other regions for transition of projects, resources and inter-regional estimates and management of inter-regional projects.o As one of the senior managers in the region, provide leadership in the implementation of PRA's business processes and achievement of its management goals and objectives within the framework of the company's mission, policy and philosophy.o Maintain an environment that attracts, develops and retains high quality staff, ensuring staff development, performance feedback and HR policies are properly implemented.o Ensure that all Quality Assurance functions are met in accordance with PRA's policies and SOPs as well as GCP and ICH Guidelines.

o Direction of Project Management for the EDC and eCRO services provided to customers globally.o Management of the Clinical Project and Data Management staff in Europe and US.o Development of the business and office infrastructure. Close customer liaison to support business re-engineering within EDC customers.o Business development and contract management.o Internal training and participation in Quality System development.

o Development of the Secondary Care business for an UK SMO including the identification of partners, structuring contracts and establishing the necessary operational infrastructure.o Implementation of the business plan to meet sales targets and demonstrate clinical research excellence for the pharmaceutical industry through training and process development.

Durham, North Carolina, Us

o Direct, supervise and develop a group of Project Managers, providing scientific support and operational advice as and when needed.o Responsible for the commercial and technical success of all projects allocated to this group.o Ensuring Customer satisfaction for all projects.o Collaboration with Business Development to ensure the acquisition and growth of new business.

o Overall direction of all aspects of the structure, function and role of BIOS’ Clinical Research Division, including financial management and development and implementation of strategic business plan. Maintenance of sponsor liaison and procurement of new business.

Education record

Mrpharms, Pharmacy

Bpharm, Pharmacy