Nicola Yarwood

Head Clinical Operations UK & Ireland

PSI CRO AG

Sep 2016 - Current (10 years)

Department management: oversight of employee's performance appraisal and promotion, hiring and dismissal of staff, contribution to the development of job descriptions. Resource management & training: Allocation of resources to projects, oversight of resource utilization, oversight of metrics on utilization/turnover/promotion/training. Development and implementation of training programs in country/region. Quality control & quality assurance: Contribute to development of quality systems, implementation of quality systems within department. Contribute to the development of intradepartmental and cross-functional quality systems documents. Development and implementation of quality controls in country/region. Collaboration with Quality Manag

Clinical Operations Manager

PSI CRO AG

Jan 2015 - Sep 2016 (1 year 9 months)

Line-management of SCRAs, CRAs, project assistants, project coordinators. Assigning resources to projects. Monitoring and evaluating reports’ performance as well as fostering individual and collective productivity. Responsibility for workload monitoring and time management for the reports Shared responsibility for organization and conduct of general and project-related training of the reports Implementation of quality control (shared responsibility) including but not limited to conducting of comonitoring visits Implementation of quality systems within the department (shared responsibility) Enforcement of corporate procedures and policies Follow-up and resolution of audit/inspection findings requiring corrective action

Head of Monitoring, CCO UK

Roche Pharmaceuticals

May 2009 - Dec 2014 (5 years 8 months)

Responsible for setting the strategic direction for the monitoring team; providing high quality leadership, management, functional expertise and coaching to ensure clinical trial monitor line managers and monitors are able to maximally contribute to the quality delivery of studies. Contribute to the development of departmental strategy, vision and objectives. Oversight of future monitoring resource needs and ensure timely, sufficient and appropriately qualified resources are available to deliver on all studies. Manage relationships with headcount suppliers of contract staff to ensure the contribution of contractors is maximized and Roche's legal and regulatory position is protected. Accountable for maintaining an overview of the executi

Line Manager

Roche Pharmaceuticals

Dec 2007 - May 2009 (1 year 6 months)

Responsible for managing a team of study managers and monitors. Project manager on a phase III Rheumatoid Arthritis study. Local alliance manager - responsible for oversight of local studies outsourced to Covance and Quintiles.

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Regional Clinical Operations Manager

Aspreva Pharmaceuticals

Dec 2005 - Nov 2007 (2 years)

Perform and document accompanied field visits with CRO monitors; perform compliance checks on vendor managed TMF. Oversight of delivery with respect to quality and study objectives (recruitment and data delivery). Represent Aspreva, assisting with the development of relationships with KOLs. Contribute to process improvement workstreams and lead the development of SOPs for the site management workstream. Global role with oversight for Northern Europe, Turkey, India, Ukraine, Israel and USA.

Clinical Operations Manager

Quintiles

Jun 2005 - Nov 2005 (6 months)

Management of a team of contract staff placed across 6 Pharma client companies. Develop relationships with Pharma monitor line managers and identify and build on business opportunities. Identify training and development needs for direct reports. Perform and document accompanied site visits. Performance reviews at mid and end of year, liaising with client managers for feedback. Perform salary and promotion reviews. Produce a monthly rolling forecast to determine revenue expectations.

CRA Field Team Leader

SANOFI AVENTIS

Nov 2001 - May 2005 (3 years 7 months)

Management of a team of field based monitors in the Midlands region. Effective allocation of resource. Interview and appoint new staff. Identify training and development needs for direct reports. Perform and document accompanied site visits. Quarterly appraisals/goal setting. Review and quality approval of site visit reports and follow up correspondence. Lead core working group to identify specific opportunities to enhance performance, productivity and study reimbursement - (site staff motivation and maximizing recruitment). Responsible monitor for a number of sites/studies (ph II to III), Lead monitor on one study.

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