Simone Schwan Email & Phone Number

State Of São Paulo, Brazil

São Paulo, São Paulo, Brazil

I am a senior professional with broad experience in Clinical Research working for Pharmaceuticals and Clinical Research Organizations in different roles - Monitor, Coordinator, Clinical Project Manager and Line Manager. I have strong experience in multinational trial for all study phases (I to IV/observational). Therapeutic areas of acknowledge: (Oncology; Anti-emetics [adult and pediatric]; Surgery [adult and pediatric]; Diabetes; Growth Hormone [pediatric]; Renal; Pulmonology; Infectious Diseases; Vaccines; Neurology; Cardiology; Urology; Gynecology; Rheumatology; Orthopedics; Ophthalmology; Otorhinolaryngology.As Clinical Project Manager, I am the primary point of contact for clients and internal team, managing project deliverables in all phases - startup, conduct, close-out. Current responsibilities include managing the operational aspects of projects to meet contractual requirements in accordance with SOPs, policies and practices; ensuring delivery of study quality and patient recruitment; driving site compliance; and leading, mentoring and training of the clinical operations team. I have been working with other operational teams as well with vendors, for example: Data Management, Biostatistics, Pharmacovigilance, EDC vendor, etc. I have extensive experience in Late Phase Studies (RWE) - observational and low interventional.As Line Manager, I manage Monitors (Site Manager and Clinical Research Associate) leading them to delivery different projects with excellence and I manage and oversee Clinical Project Managers that have less experience in that role. I am involved in the unit decisions for Americas, as region, working to improve our response to the business necessities.

São Paulo, Brazil

São Paulo, Brazil

São Paulo Area, Brazil

São Paulo Area, Brazil

Acting as responsible for the clinical part of the company in Brazil and point of contact for other decisions.I was responsible for training and monitoring of a clinical research study in ophthalmologic área conducted in 5 hospitals in Brazil. Participation in the preparation of the regulatory package (National Agency - ANVISA ) and the ethical package (ERC and National ERC) for an Otorhinolaryngology project. Evaluation of International Projects for the Brazilian clinical research area, including contacting potential investigators and perform validation visits at sites.Participation in active search for new projects contacting and making visits in sponsors presenting the company, including project budget discussions.I searched and contact potential partners for the company as translators, statistical analysis , suppliers of electronic clinical report form.I followed the importation process for clinical supplies being responsible pharmacist to ANVISA, responsible for signing the clinical research dossier.

São Paulo Area, Brazil

Participation in the monitoring of clinical trials for MSD Sponsor. Same job described during period at MSD.

São Paulo Area, Brazil

Participate in the implementation and monitoring of some clinical studies with Raltegravir, in one of them I we had to request to Headquarters and ANVISA the post-study medication and it was approved.Great experience implementing and monitoring pediatric studies - surgical and chemotherapy. We had the approval of an application for a post-study request for a subject of the study at ANVISA and Headquarters. Assigned as blinded monitor in a surgical project, the challenge was the communication of both teams, blinded and unblinded. The Project was a success.Experience in conducting trials on: oncology (lung cancer); anti- emetics (Emend); diabetes (Januvia); diabetes in renal chronic patients and insomnia.Responsible for performing validation visits for new projects in several site/areas: antifungal infection, insomnia, hepatitis, migraine, Alzheimer's disease, atrial fibrillation, etc.Assigned as Change Agent in the medical department during the merger of MSD with Schering Plough. The challenge was to seek dissatisfaction situations within the group and share them with the medical director offering suggestions for improvements. Award received in April 2012 granted by the Director of Latin America.Responsible for mentoring junior monitors and trainees, including the following activities: general trainings (protocols, system, SOPs), performing quality Control Visits at sites, monitoring training visits with trainees and revision of monitoring visit reports. Paricipate along with other CRAs and Managers in the Improvement Process in medical dept: revision of SOPs, flow charts and internal processes.Experience conduct more than 10 studies at same time

São Paulo Area, Brazil

Participate of vaccine projects in HIV and HPV (men and women). In the HPV vaccine's project in women, Brazilian centers were the world champions in recruitment for two phase III studies, including approximately 1500 and 800 volunteers. I was involved in HPV vaccine's project since phase II. During these vaccine studies MSD started the process called Continuous Data Flow (3 days to complete and submit study data to Sponsor), where I actively trained the centers to comply with the target.Responsible for two centers in a project of depression, the Brazilian participation in the project was significant, we included the largest number of patients in the world.Responsible monitor for 2 centers in an project of antiemetic drug in gynecological surgery. We were the largest recruiters worldwide for this study, the goal was to include 25 patients in each center, we included 95 and 60 patients. An audit was performed without serious findings and I received an award in 2006 for this project.Assigned to participate on a project called "Centers of Excellence " where some important centers in Brazil were choosen to receive training to improve their internal processes. We focus Process Improvement, Lean & Six Sigma, Division of Responsibilities and SOPs. A Certificate of Recognition was received on October 2005 in the meeting of Medical Directors

São Paulo Area, Brazil

Assigned to participate in the first project of the HPV vaccine (Gardasil) in women conducted in Brazil, project phase II in 3 centers. We included more than 100 volunteers in the study. It was a challenging project for several reasons: inclusion of healthy volunteers; some under 18 years; inexperienced centers in conducting clinical trials; high number of volunteers and data used to submission of NDA ( " New Drug Application " Assigned to work in a diabetes program where I had to train centers in various unusual procedures at the country in that moment.Assigned to monitor some small studies: arthritis, osteoarthritis and dyslipidemia projects; monitoring and closure of HIV study with ritonavir.

São Paulo Area, Brazil

• My main activity was monitor phase IV studies. • Assigned to work in the implementation of Viagra studies in Brazil during the product launch process. I had the experience contacting influencers doctors in urology.• I was assigned to monitor projects of antifungal drugs in gynecology and cardiovascular products.

São Paulo Area, Brazil

• My main activity was the monitoring of other monitors in projects phases III and IV, especially studies of ritonavir. • I was assigned to monitor a growth hormone study, under the supervision of the manager.• I had the experience on data entry from several studies, but mainly Ritonavir.

Extension Course In Business Administration

Green Belt Certified (Lean Six Sigma Metodology)

Mba, Marketing

Bachelor Of Pharmacy - Bpharm, Pharmacy

University, Pharmacyst Biochemistry

Activities and Societies: CRF-SP (Regional Council of Pharmacy)