- Manages team of UK based Data Managers, responsible for recruitment and performance appraisal of team- Provides input into departmental resourcing, training, process development and improvement- Acts as Data Management project supervisor- Provides input into proposals and data management strategy for business development- Input into company risk management procedures and implementation from a DM perspective

- Act as lead Data Manager on a number of large, global Phase II/III studies- Responsible for management of EDC vendors (Medidata, Oracle)- Primary responsibility for all DM activities from CRF set-up through to database lock- Inputs into Data Management proposals and presents at bid defense meetings

• Project lead for a number of stand-alone biometrics projects, with oversight of statistical, medical writing and pharmacovigilance activities, ensuring overall quality and adherence to study timelines.• Responsible for project scope and budget management; monthly forecasting, invoicing and negotiation with clients regarding out of scope costs.• Acts as the key data management contact at internal and sponsor team meetings, providing updates on project status and advice on key issues.• Back-up for Director of Clinical Data Management, as required.• Responsible for the line management, training and career development of a group of data management staff. In addition, provide technical support and training for US colleagues.• Work with the Data Sciences leadership team to determine departmental resourcing needs and assist with recruitment of staff.• Review and input into proposal costs and strategy and representation of data management at bid defence meetings.• Involved in the creation and maintenance of departmental SOPs, data management tools and training documentation to ensure harmonisation of global processes.

• Act as lead Data Manager, with sole responsibility for the co-ordination of all data management activities from initial set-up through to database lock in accordance with ICH-GCP and SOPs.• Set-up global EDC studies, including creation of eCRF specification documents, user acceptance testing, development of study manuals and implementation of training to team members, both internally and at study sites.• Oversight of quality control procedures and medical coding for all projects within the data management department.• Attendance at internal and sponsor audits as well as participating in three MHRA Inspections for data management activities.• Input into company EDC strategy, including selection of EDC system and development of company EDC SOPs.• Eudravigilance reporting of individual case safety reports (ICSRs).• Support in the development of proposals for potential new business.

• Case Report Form and diary card design and creation of data management documents, such as CRF Completion Guidelines, Data Management Plans and Data Validation specifications.• Input into and review of clinical trial protocols.• Review and approval of database design documentation, such as the database model, data entry specifications and annotated CRF.• Design, testing and maintenance of clinical trial databases.• Data cleaning activities including manual and electronic data review, data query management, SAE/AE reconciliation and quality control of clinical trial data.• Medical dictionary coding (MedDRA, WHODrugs)• Review of statistical analysis plans and study specific tables, figures and listings.• Liaison with external vendors to coordinate data transfer specifications, timelines and reconciliation of central laboratory data.• Training on data management requirements at Investigator Meetings and project specific CRA training.• Pharmacovigilance activities including SAE processing (receipt, coordination of medical review and follow-up with investigational sites) and input into SUSAR reports and annual safety reports.• Provided clinical administrative support to Project Managers and Clinical Research Associates. Included maintenance of trial master files and documentation, tracking of clinical trial progress including essential documents and patient recruitment.

• Involved in data entry, verification and editing of clinical trial data for a large Phase III oncology study.• Assisted the lead DM with raising data queries, medical dictionary coding, review of laboratory data and quality control checks.