- Pharma professional with more than 7 years of clinical research experience, having worked on various multinational Phase I, II and III clinical trials.
- Primarily focusing on Oncology studies although I also have experience in Hematology and Neuroendocrine clinical trials.
- A team player with strong communication and problem solving skills
Senior Clinical Manager @ From March 2014 to Present (1 year 10 months) Medical Science Liaison (MSL) @ - Development of partnerships with investigators, opinion leaders and healthcare professionals, evidence based communication and education;
- Pipeline presentations;
- Clinical trial activities - Medical feasibilities, supporting clinical trial patient’s recruitment, identify new potential sites for clinical trials;
- Investigator-initiated trials (IITs);
- Scientific projects & research Publications;
- Scientific support to marketing teams;
- Input and/or attendance at medical educational programs, advisory boards, congress, training. From August 2012 to March 2014 (1 year 8 months) São Paulo Area, BrazilSenior Clinical Research Associate @ - Lead CRA for several Oncology studies working together with the International clinical team, CRAs and clinical trial sites
- Experienced in feasibility meetings
- Preparation and performance various types of site monitoring activities (i.e., Site selection, Initiation, monitoring and close-out visits) according to ICH GCP, SOPs and other regulatory requirements.
- Responsibility of enrollment planning and management. Follow-up clinical trial timelines, recruitment, goals & logistic (drug and materials) to meet target patient enrolment.
- Development and implementation of corrective action-plans for the non compliant sites.
- Organization and implamentation of presentations and trainings to Investigators during local investigator meetings and initiation visits. From March 2012 to August 2012 (6 months) São Paulo Area, BrazilClinical Research Associate @ - Study selection, initiation, monitoring and close-out visits for phases II and III, international, multicenter, randomized or single-arm, double-blind or open studies in the Oncology, Hematology and Neuroendocrine tumor areas such as breast cancer, lymphoma, myeloma, kidney cancer, leukemia, acromegaly, GIST and melanoma.
- Development of exceptional communication skills through the direct communication and training of investigators and staff. I also planned a local Investigator’s meeting and participated in international Investigator’s and Monitor’s Meetings.
- Experienced in drug accountability, utilization of paper and electronic CRF, file/archive organization, drug and laboratory kits import, budget and contracts review, payments, SAEs review, monitoring reports and follow-up letters.
- Worked as unblinded CRA in double-blind study.
- Study start-up – Lead CRA in several Oncology studies. I was responsible for preparing the study sites for the FPFV and management during the study: Feasibility meetings, site selection visits, Site initiation visit, Development of monitoring tools, Global teleconferences, Queries control
- eCRF super user – responsible for the overall user training for Brazil and support of CRAs and investigator sites.
- Active participation in 2 hematology studies audits as a CRA.
- Was responsible for Novartis electronic database management for the Brazilian region. From October 2007 to March 2012 (4 years 6 months) Pediatric Dentistry @ From January 1999 to July 2008 (9 years 7 months) Trainee at Clinical Research and Regulatory Affairs Department @ - Contact with clinical sites to follow up outstanding issues, obtaining documents and schedule visits.
- Sending pharmacovigilance letters (CIOMS) to clinical sites.
- Clinical research Training about Good Clinical Practice and Internal SOPs.
- Co-monitored a study site visit;
- Source data verification;
- Follow up Letter;
- Preparing Investigator Folder;
- Submissions monitoring of regulatory documents (original dossiers, amendments and other reports) to ECs, CONEP and MoH.
- Communication with the sites and sponsor.
- Sent CIOMS to sites and local EC.
- Trained of Brazilian regulations. From April 2007 to July 2007 (4 months) São Paulo Area, BrazilProfessor of Pediatric Dentistry in graduate and postgraduate level @ From January 2003 to December 2004 (2 years) São Paulo Area, BrazilTrainee at the Department of Pediatric Dentistry @ From January 1998 to December 2002 (5 years) São Paulo Area, Brazil
Master's degree, Dentistry and Orthodontics @ Centro Universitário Hermínio Ometto de Araras From 2006 to 2008 Post-Graduate, Clinical Research @ Hospital Central da Irmandade da Santa Casa de Misericórdia de São Paulo From 2007 to 2007 Post-Graduate, Pediatric Dentistry @ Universidade PaulistaGraduate, Dentistry @ Universidade Paulista From 1994 to 1997 Flavia Kiertsman, DDS, MS is skilled in: Oncology, Clinical Research, Clinical Monitoring, Hematology, Teamwork, Clinical Trials, ICH-GCP, Regulatory Affairs, GCP, CRO, Healthcare, Pharmaceutical Industry, Clinical Development, Sop, Therapeutic Areas