Clinical Trial Support
Bayer Portugal, SA
Since February 2014
Country Executive Management Support, namely implementation of SOP’s and local Quality System Management for Clinical Trials. Compliance with GCP and applicable laws and regulations. Quality Control, including Trial Master File quality check, quality review of site contracts and translation of essential documents of multinational clinical trials for submission to Ethics Committee and Health Authority. Support to Audits and Inspections. Data entry and maintenance of study tracking databases and internal document systems. Prepare and review Investigator Agreements and Financial Contracts. Financial – budget tracking and review. Interdepartmental and cross-functional relationships (Medical Dpt, Legal Dpt, Finance Dpt, Procurement Dpt, Quality and Compliance). Training development and implementation.
(exclusively performing Clinical Trial Support activities since January 2013)
Since February 2014
Country Executive Management Support, namely implementation of SOP’s and local Quality System Management for Clinical Trials. Compliance with GCP and applicable laws and regulations. Quality Control, including Trial Master File quality check, quality review of site contracts and translation of essential documents of multinational clinical trials for submission to Ethics Committee and Health Authority. Support to Audits and Inspections. Data entry and maintenance of study tracking databases and internal document systems. Prepare and review Investigator Agreements and Financial Contracts. Financial – budget tracking and review. Interdepartmental and cross-functional relationships (Medical Dpt, Legal Dpt, Finance Dpt, Procurement Dpt, Quality and Compliance). Training development and implementation.
(exclusively performing Clinical Trial Support activities since January 2013)
Medical Translator and consultant
Freelance
Since September 2005
Translation and proof-reading of scientific and promotional materials, e-learning, web pages and product information, as well as clinical translations (EN>PT, SP>PT). Regulatory affairs and pharmaceutical regulation consultant (Medicines, Cosmetics and Medical Devices). Clinical Trial Monitoring (Oncology, Phase III – 2009/2014).
Since September 2005
Translation and proof-reading of scientific and promotional materials, e-learning, web pages and product information, as well as clinical translations (EN>PT, SP>PT). Regulatory affairs and pharmaceutical regulation consultant (Medicines, Cosmetics and Medical Devices). Clinical Trial Monitoring (Oncology, Phase III – 2009/2014).
Clinical Trial Assistant
Bayer Portugal,
SA
July 2008 – January 2014
Trial Master File – set up and maintain clinical files/documentation; Coordinating role for the study team concerning administrative matters; Submission of studies to Central ethics Committee (CEIC), Health Authority (INFARMED), National data Protection Committee (CNPD) and Hospital Administration Boards; Prepare Investigator Agreements, investigator payments and tracking systems; Organize study-related documents and other materials for delivery to file/archive; Prepare monitoring visit documentation for CRAs, as requested; Provide clerical support to study team, e.g. word processing, proofreading and editing correspondence, mailing, shipment of study files, assemble of study documents, arrange meetings and travel booking arrangements; Data entry and maintenance of study tracking databases.
September 2013 Bayer’s Global Clinical Development Innovation Award
July 2008 – January 2014
Trial Master File – set up and maintain clinical files/documentation; Coordinating role for the study team concerning administrative matters; Submission of studies to Central ethics Committee (CEIC), Health Authority (INFARMED), National data Protection Committee (CNPD) and Hospital Administration Boards; Prepare Investigator Agreements, investigator payments and tracking systems; Organize study-related documents and other materials for delivery to file/archive; Prepare monitoring visit documentation for CRAs, as requested; Provide clerical support to study team, e.g. word processing, proofreading and editing correspondence, mailing, shipment of study files, assemble of study documents, arrange meetings and travel booking arrangements; Data entry and maintenance of study tracking databases.
September 2013 Bayer’s Global Clinical Development Innovation Award
Trainer
Pharma Nord
September 2005 – July 2008
Training sessions on nutritional supplementation in Pharmacies and for new employees; Translation of technical materials.
September 2005 – July 2008
Training sessions on nutritional supplementation in Pharmacies and for new employees; Translation of technical materials.
Regulatory Affairs Officer
Schering
Lusitana, Lda.
September 2003 – July 2005
Regulatory Affairs; Technical Director of Lusal – Produção Química-Farmacêutica Luso-Alemã, Lda., Schering AG’s subsidiary since May 2004; Pharmacovigilance – Drug Safety Officer.
September 2003 – July 2005
Regulatory Affairs; Technical Director of Lusal – Produção Química-Farmacêutica Luso-Alemã, Lda., Schering AG’s subsidiary since May 2004; Pharmacovigilance – Drug Safety Officer.
Medicines License Manager
INFARMED –
National Authority of Medicines and Health Products, IP
March 2001 – September 2003
Medicines License Manager in Medicinal Products for Human Use Department; Portuguese participation on NTA – Notice to Applicants, European Commission and TIGes – Telematic Implementation Group for e-Submission; Collaboration on guidelines and legislation; Trainer for internal Practice on CTD.
March 2001 – September 2003
Medicines License Manager in Medicinal Products for Human Use Department; Portuguese participation on NTA – Notice to Applicants, European Commission and TIGes – Telematic Implementation Group for e-Submission; Collaboration on guidelines and legislation; Trainer for internal Practice on CTD.
Medical Information Officer Trainee
Roche
Farmacêutica Química, Lda.
September 2000 – February 2001
Scientific Information Support and RocheNet - Regulatory Affairs and Professional Services Department.
REFERENCES Available on request.
September 2000 – February 2001
Scientific Information Support and RocheNet - Regulatory Affairs and Professional Services Department.
REFERENCES Available on request.