Windsor, England, United Kingdom
Highly motivated, adaptable & results driven project data manager with over twenty-five years’ experience within the pharmaceutical & CRO industry. Possesses strong project management and leadership skills with focus on delivery within cross functional teams. Takes on new challenges with enthusiasm, methodical and ‘can do’ approach. Passionate about building strong trusting relationships with team members and external partners and championing continual process improvements. An approachable and respected team player continually working to high standards in an often-high pressurised environment. Currently employed by GSK as a project data manager.
• Single point of accountability for DM deliverables at an asset level for a high priority Infectious Diseases clinical development programme. • Project manage all aspects of the data management activities for one or more clinical studies; ensuring studies are adequately resourced, managing vendor relationships & work, and ensuring robust study data quality. • Lead discussions with the clinical study matrix team to develop data cleaning strategy and data management plans for a clinical study. • Determine the data requirements for a clinical study including the eCRF, laboratory and eCOA • Identify risks around meeting key study milestones and required data quality; facilitate discussions including those around central monitoring with study team and key stakeholders to identify risks, and to ensure that appropriate contingency plans / corrective and preventative actions are developed and implemented where necessary. • Providing strong leadership and oversight of DM deliverables with CROs. • As Inform 6.2 Migration Co-Ordinator managed the migration schedule with Oracle, demonstrating effective organisational & communication skills, stakeholder management, and relationships building with cross functional team including vaccines counterpart, IT colleagues & Oracle team. • Involved in selection & recruitment process of industrial placement students and contingent workers. • Developed strategic solution with a new vendor with novel technology, providing DM input into 3-day workshop to understand vendor system and agree ways of working based on GSK guiding principles. • Building data management capability by proving input into departmental training materials and delivering relevant training for GSK & offshore partner data managers including onsite training in Mumbai. • As Study Data Manager on several studies in both Respiratory, and Infectious Disease therapy areas, ensured instream high data quality throughout the studies reducing timelines for essential decision making.
• Engaged with EDC vendor with respect to set up of Oncology trials • Key data management representative on internal EDC team to review implementation processes • CRO assessment for outsourcing of data management activities • Protocol and CRF review
• Project Manager / Lead Data Co-ordinator of assigned studies for a wide range of clients / systems within differing therapeutic areas, including a large global Phase III study in Women's Health, and a European Phase II study • Line management responsibilities • Mentoring of junior data managers • Overseeing the financial and contractual aspects of studies • Seconded to Ipsen (Apr 2003 - Jan 2004); seconded to Novo Nordisk (Dec 1999 - Jul 2000) Secondment I (Novo Nordisk, Copenhagen , Denmark) Project Data Manager • Planning, co-ordinating & supervising data management activities with affiliated Clinical Data Centres and CRO for assigned Diabetes study • Close liaison with project team Secondment II (Ipsen), Slough Project Data Manager • Engaged with EDC vendor with respect to set up of Oncology trials • Key data management representative on internal EDC team to review implementation processes • CRO assessment for outsourcing of data management activities • Protocol and CRF review
• Line management of six Data Managers • Project management of dementia study • Managing resources across assigned projects • Costing of new projects • Database design and set-up • Supervision of Data Managers / Data Entry operators
• Handling laboratory data • Coding of adverse events, diseases, and drugs
• Study responsibility including reviewing and computer validation of information resulting from clinical trials • Handling laboratory data • Reviewing CRF’s and protocols