Anna Pratt Email & Phone Number

London, United Kingdom

• Liaise with study sites regarding Central and local Ethics Committee Submissions and approvals, R&D submission and approvals, Site contract and budget negotiations and essential document collection.• Perform the CEC submission for the UK.• Customise country/site specific Patient Information Sheet and Consent Forms.• Review study documents as required, e.g. patient-directed materials• Drug Release Checklists.• Provide regular local status updates to the Global Study Start Up (GSSU) Manager; updates provided using the study-tracking tools with local essential document and ethics committee status, when required.• Assist Feasibility Group with conduction of feasibility studies as required.• Assist project teams with site selection activities as required.• Ensure all relevant documents are submitted to the Trial Master File (TMF)

- Direct line management of PRAs.- Training and coaching for strong performance.- Conducting performance management.- Following-up of key performance indicators.- Assisting the Global Head of the PRA team with theselection and recruitment of PRAs.- Provide administrative support and work closely with theproject manager & project team providing critical support inthe planning, execution, & control of clinical studies, toensure objectives of the project are met.- Provide guidance regarding company policies andprocedures.- Participate in the conduct of training needs analysis ofeach employee to develop and manage individualizedtraining and development plans.- Assist in training as required.- Participate in quality assurance audits conducted internallyor with the sponsor as required.- Quality checking of clinical documents.