Mariano Monteagudo
About
Mariano Monteagudo is from Argentina. Mariano works in the following industries: "Pharmaceutical Manufacturing". Mariano is currently Director Strategy Business Development Latam & Partner at Activa-Cro, located in Greater Buenos Aires, Argentina. Mariano also works as Director Strategy Business Development Latam at Activa-Cro, a job Mariano has held since Dec 2014. Another title Mariano currently holds is Clinical Project Manager at Activa-Cro. In Mariano's previous role as a Clinical Operation Manager/Clinical Project Manager at Glaxo SmithKline Pharmaceutical, Mariano worked in until May 2013. Prior to joining Glaxo SmithKline Pharmaceutical, Mariano was a Quality Assurance Manager at GlaxoSmithKline Pharma GmbH and held the position of Quality Assurance Manager at Argentina. Prior to that, Mariano was a Clinical Research Scientist at GlaxoSmithKline Pharma GmbH, based in Argentina from May 2005 to Jan 2007. Mariano started working as Sr CRA and Project Leader at Glaxo SmithKLine Pharmaceutical in Jan 2004. From May 2003 to Jan 2004, Mariano was Sr CRA at Latin Trials. Prior to that, Mariano was a Sr CRA : Argentina and Chile at MDS Pharma Services from Sep 2002 to May 2003. Mariano started working as CRA at MSD Sharp & Dohme in Aug 2001.
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Mariano Monteagudo's current jobs
Description: Responsible of the Business Development Strategy in the following countries: Argentina, Chile, Uruguay, Brazil, Peru, Colombia, Panama and Mexico. Responsible for prepare budgets, RFP and RFI for the clients. Responsible for prepare VQA from Sponsor or others CRO. Interact with the following Business Unit: Clinical Operation, Medical Affairs, Legal, Finance, Safety and Quality Assurance. Implement web strategy campaigns of our site. Participate in the BID Meetings. Report Direct to the Board of Directs. Identify key opportunities in the region. Participate in the resourcing strategy in the region. Building and maintain relationship with Sponsor, CRO and vendors. Responsible of vendor management. Therapeutic Expertise: Oncology (Phase III): Breast Cancer & Prostate Cancer Diagnostics: Prostate Cancer and Knee Replacement (Pivotal ) Cardiovascular: Atrial Fibrillation (Registry) Neglected Disease: Chagas Disease (III) Orphan Disease:aHUS adults, Fabri, Pompe & Gaucher Disease ( Registry) Immunoinflammation: SLE ( III)
Description: Coordinate activities with SrCRA & CRAs – CRAs management : 4 (Internal & External FTE)-CTA management : 4 - CRAs Workload - CRAs PDP evaluations- Retention Strategy of CRAs-Follow up regulatory process-Identification of CRA Needs- Feasibility Process- Budget Process-Identify people development opportunities and training needs- Review Monitoring report –Communication with clinical matrix team and regulatory parties – Regional activity: Argentina, Peru, Colombia & Mexico- Budget & Contract Management- Vendor Management & Selection Therapeutic Expertise: Oncology (Phase II and III): Breast Cancer & Prostate Cancer Diagnostics: Prostate Cancer and Knee Replacement
Mariano Monteagudo's past jobs
Coordinate activities with SrCRA & CRAs – CRAs management : 10 (Internal & External FTE)-CTA management : 4 –-CRO Negotiation - CRAs Workload - CRAs PDP evaluations- Retention Strategy of CRAs-Follow up regulatory process-Identification of CRA Needs- Feasibility Process- Budget Process-Identify people development opportunities and training needs- Review Monitoring report –Communication with clinical matrix team and regulatory parties-Feasibility Manager- Quality Control & Risk Management Manager-Recruitment and Retention Strategy of sites- Responsible as CPM of 800 patients Therapeutic Expertise: Oncology (Phase II and III): Breast Cancer, Head and Neck, Lung Cancer, Cervix Cancer and Oncology Adjutant Therapy Neuroscience (Phase II and III): Alzheimer Disease, Major Depression and Epilepsy Metabolic (Phase: Ib ,II ,III and IV): Diabetes II, Osteoporosis, Wrist Risk Fracture, Pre-term Labor , Hyperlipidemia, SERMs in Hot Flashes. Cardiovascular (Phase II and III): Acute Myocardial Infarction, Congestive Heart Disease, Atrial Fibrillation, Congestive Heart Disease with IVUS Respiratory (II, III and IV): Asthma, COPD and Seasonal Allergic Rhinitis Infectious (III): HIV Inflammation and Pain ( II and III): Osteoarthritis, Rheumatoid Arthritis and Systemic Lupus Erythematosus adults and pediatric population ( SLE) Rare Disease (II): Pulmonary Arterial Hypertension (pediatric), Chronic Thromboembolic pulmonary hypertension (CETPH), Hunter Disease and Duchenne Disease. Number of protocols in each unit: Oncology: 8, Metabolic: 10, Cardiovascular: 12, Neuroscience: 10 , Respiratory: 13 ,Infectious: 6 and Rare Disease: 4 , Immunology: 10 and Pediatrics: 4.
Description: Risk Management Matrix- Perform quality control visits to sites- Develop risk mapping matrix for clinical sites in all the study phases. Collaborate with the clinical team before and during MoH Inspections, IEC inspections and Site audits. Prepare the sites as Inspection readiness. Perform in site and off site quality control visit. Share the lessons learned with the clinical staff. Collaborate with the medical affairs team with the preparation of GIA audits and Ethics Global Audit. Collaborate with Finance team for the preparation of the Investigators Payments audit. Total of qc visit performed: MoH Inspections: 10- Audits:8- GIA: 1-Finanace audit: 1- Ethics Audit: 1-Site QC visits:10 Therapeutic Expertise: Oncology (Phase II and III): Breast Cancer, Head and Neck, Lung Cancer, Cervix Cancer and Oncology Adjutant Therapy Neuroscience (Phase II and III): Alzheimer Disease, Major Depression and Epilepsy Metabolic (Phase: Ib ,II ,III and IV): Diabetes II, Osteoporosis, Wrist Risk Fracture, Pre-term Labor , Hyperlipidemia, SERMs in Hot Flashes. Cardiovascular (Phase II and III): Acute Myocardial Infarction, Congestive Heart Disease, Atrial Fibrillation, Congestive Heart Disease with IVUS Respiratory (II, III and IV): Asthma, COPD and Seasonal Allergic Rhinitis Infectious (III): HIV Inflammation and Pain ( II and III): Osteoarthritis, Rheumatoid Arthritis and Systemic Lupus Erythematosus adults and pediatric population ( SLE)
Description: Coordinate activities with SrCRA - New CRAs-Trainer for new sites – Training on Start Up meetings– CRAs managed 6 (internal and external)- CRAs - Feasibility Process- Communication with clinical matrix team and regulatory parties- Identify people development opportunities and training needs- Responsible as CRS of 600 patients Therapeutic Expertise: Inflammation and Pain: Rheumatoid Arthritis Urology: Prevention of Prostate Cancer
Site Quality Control New CRAs training. Training for new sites Training on Start Up meetings. SAEs monitoring and follow-up CRO Management- Therapeutic area expertise: Inflammatory and Urogenital
Site Quality Control New CRAs training. Training for new sites Training on Start Up meetings. SAEs monitoring and follow-up End-points monitoring and follow up Therapeutic Expertise: Osteoporosis
Project Leader in Argentina and Chile Monitors training Sites selection Monitoring reports review and follow-up. Coordinate sites, ECs and regulatory authorities in Chile. Area: Allergy protocol and Lung Cancer
Site Initaition Site Monitoring activities Cardiovascular , Sepsis and HIV protocols.
Monitoring activities at sites Site initiation – Study files – SAEs – Aes Therapeuti Area: Asthma and Cardiovascular protocols
Description: Monitoring activities at sites – Site initiation – Study files – SAEs – Aes-Filing activities-Communications with clinical matrix team and regulatory parties. Therapeutic Expertise: Respiratory: Asthma Cardiovascular: Congestive Heart Disease.
Physicina Trainer Intranet Web developer: Intranet and Clinical Reserach Activities Promotion ACtivities: Xenical