Ana Vazquez, M Psy Email & Phone Number

Zug, Suiza

Zug, Suiza

Neuchâtel Area, Switzerland

Neuchâtel Area, Switzerland

Neuchâtel Area, Switzerland

Global CTA, in collaboration with the CTManager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. • Provide operational input on development, management and maintenance of study deliverables• Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution• Lead / Participate in monitoring visit report review process • Support Health Authority inspections and CQA audits as required • Ensure full compliance of the required data in study management tools • Proactive identification of potential risks and development/implementation of actions • Develop and maintain collaborative relationships with internal and external partners/stakeholders • Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution • Participate in vendor specification development and management/oversight • Manage TMF set-up, ongoing quality review, and final reconciliation• Reconcile IP at study level • Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes…)• Contribute to development / coordination of study training • Contribute to ordering and distribution of materials as required • Manage study-level IP shipment to sites• Manage collection, review and tracking of study documents as necessary• Assist with Investigator meeting coordination and planning• Assist with compilation of Clinical Study Report appendices• Manage vendor and site payment processing and tracking • Assist with maintenance of study budget tracking tools and reconcile invoices • Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.

Barcelona, Cataluña, España

Assistance in developing team members’ knowledge of the disease under study. Strong leadership skills, working effectively with different types of people. Focus on resolving problems, making sound decisions within the scope of responsibility. Coordination of several projects in Hematology at the same time (about 30). Active assistance and follow up in each stage of every project, since the preparation of the concept sheet and protocol, obtaining regulatory approvals, attending pharmacovigilance requirements, medication supply, contracts, review of statistical analysis and submitting the clinical study report and further publications. Patient recruitment achieved in timeline. Data collection completed according to project plan.Strategic development and implementation of large phase I, II, III and IV clinical trial programme (50 protocols and all study related documentation) in hematology therapeutic area. The programme was time critical to protect company’s key product from competition. Identification and selection of CROs and others vendors (mostly regarding medical devices supply) to help performing clinical trials. Responsible to make contracts with them and becoming the line manager in charge to following, review and help them with issues (if needed).CRA resource allocation decisions were made in collaboration with Project Managers. Creation and delivery of CRA induction programme for all newly recruited CRAs. Selection and recruitment of external training services to meet CRAs’ training needs. Corrective action plans put in place to improve performance. Successful management, performance and development of team resulted in better use of resources, higher quality monitoring.Identification, co-ordination and tracking of 100+ Spanish study centres to timelines, included all submissions to Ethics committees and collection of essential documentation.Good knowledge of GCP/ICH Guidelines and regulatory requirements.

Barcelona, Cataluña, España

Responsible for managing and implementing projects. Resources allocation to projects, also in charge of its assessment, monitoring and control. Preparation and management of budgets. Preparation of synthesized information to the proper management from Biometric Group and getting involved in the development of global strategies. Review of working papers and close supervision of each protocol set window. New activities promotion. Customer responsible: serving customers on technical, methodological and administrative issues. Active contact with costumers to promote new activities and studies.Head of Clinical Study Coordinators Team (20 site coordinators): supporting issues and efforts in management of clinical studies, and assist in defining training needs of staff. Definition of coordination processes and information flows specification in order to contact with each clinical study site coordinate to keep updated the whole activity’s information of Trialnet.

Cataluña, Comunidad Valenciana And Murcia, Spain

Obtaining, maintaining and updating the documentation concerning the clinical trial (investigator file)Medication management (surveillance of delivery and return of the drugs under study and assessment of therapeutic adherence) and active monitoring of concomitant medication.Detection and notification of Adverse Events and Serious Adverse Events within the required timeframe.Queries resolution.Responsibility to schedule appointments for patients and further testing (same service / hospital or other) following the timetable set by the protocol.Laboratory stock management in order to provide the hospital with the whole equipment needed to perform analysis (tuve kits, requisition forms, dry ice. ). Completion and submission of samples and accompanying documentation.Continous review of medical records and laboratory reports, both in the laboratory local such as external laboratorios.Attention to monitoring visits and audits.Management and updating of the CRFs (physical and electronic) in the required timeframes.Collaboration in patient recruitment.PHASE / CLINICAL TRIAL / PHARMACEUTICAL COMPANY / HEALTHCARE SEVICE / HOSPITAL:Phase II -CL2-38093-009-Servier Laboratory- Neurology/Bellvitge Hospital (Barcelona). Accreditation as a supervisor of the neuropsychological battery administration.Phase IIb -AVA102675-GlaxoSmithKline- Neurology/Bellvitge Hospital (Barcelona)Phase IIb -AZ3110866-GlaxoSmithKline- Neurology/Bellvitge Hospital (Barcelona)Phase II -V00191 PO 202-Pierre Fabre Laboratory- Neurology/Bellvitge Hospital (Barcelona)Phase III -AAB-001, 3133K1 – 3000/3001-Wyeth/Pfizer- Neurology/Sant Pau Hospital (Barcelona)Phase III -ACC-001, 3134K1-200-EU-Wyeth/Pfizer- Neurology/Sant Pau Hospital (Barcelona)Phase III -TPL103922-GlaxoSmithKline- Digestive/Bellvitge Hospital (Barcelona)Phase III -TPL108390-GlaxoSmithKline- Digestive/La Fe Hospital (Valencia) and Hospital del Mar (Barcelona)ETC