Sarah Langley Email and Phone Number

EU Project Manager for a Global Phase 3 Oncology study. Liaise with the CRO, vendors and US Study Leads on a daily basis to discuss protocol compliance issues, budgets/contracts, SAEs, progress reports, data extraction and training. Experience in two EU site inspections, data locks and close out tasks.Responsibilities include: • Study lead for 7 EU countries and primary point of contact for vendors, CRO and cross functional teams. • Regular calls with the CRO, Finance and Legal teams to discuss the progress of site contract amendments • Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and EU regulations.• Vendor management including budget review.• Review monitoring trip reports and track resolution of all actions items.• Check clinical data listings for completeness and accuracy and escalate issues to appropriate stakeholders• Evaluate protocol deviations and liaise with the study team to plan and implement strategies which reduce risk of further occurrences. • Participated in Quality Control Monitoring and Co-Monitoring Visits to assess the CRA and ensure sites are adhering to the protocol.• Provide input into the study related materials such as Monitoring Plan, Pharmacy Manual, eCRF completion guidelines and Study Newsletters.

Perform clinical monitoring activities, close out visits and audit preparation on a Phase 2 Alzheimer’s Disease Psychosis trial.Responsibilities include:• Ensure safety of subjects and compliance with the study protocol, monitoring plan, SOPs, ICH/GCP guidelines and contractual timelines.• SDV and reconciliation of patient data through to database lock.• Train and mentor new CRAs.• Create and maintain appropriate documentation of visit findings by submitting regular reports, generating follow-up letters and action plans.• Liaise with global project management, quality assurance, data management and sponsor representatives to give updates on the UK status.• Design and update trackers on ICFs, SAEs and prohibited medications.• Quality control on TMF.• FDA/MHRA audit preparation.

Extensive remote and site monitoring on Oncology, Immunology and Women’s Health protocols simultaneously across UK sites for a large Pharmaceutical company. Experience in study start up through to study close out.Roles and responsibilities included: • Study Leading on a Phase 3 Lung Cancer trial overseeing 15 UK sites and 6 CRAs. Track regulatory submissions and approvals, site activity and enrolment. Main UK contact for the Global PM.• Cover all aspects of study site monitoring, including site selection, initiation, on site monitoring, remote monitoring and close-out visits. CRA on Phase 3 Lung Cancer, Phase 3 Breast Cancer, Phase 2 Ovarian Cancer and Phase 3 Women’s Health.• Train and mentor CRAs. Assist with writing trip reports and co-monitoring visits.• Facilitate and work closely with sites for Interim and final database locks.• Ensure that sites submit data on eCRFs in a timely manner, including appropriate reporting and follow-up for all safety events.• Ensure regulatory inspection readiness at assigned clinical sites.• Implement appropriate activities to ensure the site meets the enrolment target within the agreed timeline. Proactively identify issues that impact recruitment.• Create initial study contracts and process contract amendments. Manage investigator payments as per executed contract obligations.• Hosted and organised a 2 day AbbVie departmental meeting for a team of 45 people.

Monitored a dermatology study across 40 sites in London/South East to ensure protocol compliance and adherence to Good Clinical Practices. Responsibilities included:• Sole administrative support and data entry for over 300 patients participating in the study at Guy’s and St Thomas’ Hospital, London. Achieved ‘Top Recruiter’ award in UK and Ireland in both March and April 2013.• Extensive CRA support for 40 sites to monitor progression of study, CRF data collection, identified study-related trends/issues and implement corrective actions when necessary. • Monitored sites to ensure they are following GCP guidelines, local SOP’s and adhering to the protocol.• Identified barriers in screening and enrolment and provided solutions.• Attended London and South East site initiation visits to train staff • Conducted structured audits at high recruiting centres across UK and Ireland.• Responded to email/phone calls on protocol-specific questions (resolution of patient eligibility questions, protocol deviations, data queries).• Presented at bi-annual dermatology network meetings to encourage recruitment and bring new centres on board.

Carried out global remote monitoring for studies in a large range of therapeutic areas. Assessed pending results, demographic holds and identified trends, including those of non-compliant sites to enable pro-active feedback to client and internal departments. As the key contact, duties were to inform sites of courier issues, advise on specimen collection and preparation. Participation in study review meetings to discuss problem resolution and protocol specific issues.

Liaised with country study leads and site contacts to co-ordinate correct clinical trial materials/documents and ensure they were supplied to sites on time for first patient arrival. Managed study set up of new centre accounts and updated the database with current investigator/contact details.