Celeste Pacheco

Background

About Celeste Pacheco

Solid experience in Clinical Research area, 22 years working in Pharmaceutical Companies within Clinical Research Department. Management of projects in different therapeutic areas (Anti-Infective, Cardiology, Central Nervous System, Metabolic Disorders, Oncology, Respiratory and Rheumatology), international trials phase II, IV, observational and local trials. Excellent inter personnel skills. Experience in preparation for Audits and Inspections. Main activities- Selection, start up, conduction and close out monitoring activities ensuring that Clinical Trials are conducting according to ICH/GCP; local legislation and SOPs- Protocols, ICF (Informed Consent Forms) and CRF (Case Report Forms) customization/preparation- Recruitment strategies to improve patient randomization- Investigator´s Meeting (IM) organization and participation- Audits support- Financial management of clinical trials including budget planning, resource allocation and contracts- Outsourcing/Local Vendors selection and management- Hiring and Coaching of CRAs and trainnes- Safety Reports management and SAEs monitoring (Pharmacovigilance activities)- Study Supplies management- Local SOPs development- Regulatory package preparation, submission and follow up in IRBs/MoH. Executive MBA in Pharmaceutical Business, completed in May 2012. In carreer transition sponsored by LHHDBM