Danilo Uvalin
Head Sponsor Oversight at PAION AG- Claim this Profile
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Bio
Michael Joseph Roehl
Danilo was my direct lead when we worked together on a phase III international, randomized trial. In this capacity, he was responsible for Sponsor Oversight of the operational CRO. His organized and transparent style of leadership made it easy and a pleasure to be a part of his team. He also impressed me with his knowledge of clinical operations, ICH-GCP and risk management. I learned a lot from working together with Danilo and would welcome the chance to do so again in the future.
Marija Pesic
Danilo and I worked together on a number of clinical trials ( from small Phase 1 to large Phase 3) which Danilo led operationally. He is experienced and self motivating lead who is not only an excellent problem solver but is actually proactively able to to anticipate and prevent issues before they happen. He is a great team player with ability to lead large cross-functional teams in a collaborative spirit. Moreover, he is always ready to do the extra mile, which is often needed to push the project forward in a timely manner. I hope we work together on more projects in the future!
Michael Joseph Roehl
Danilo was my direct lead when we worked together on a phase III international, randomized trial. In this capacity, he was responsible for Sponsor Oversight of the operational CRO. His organized and transparent style of leadership made it easy and a pleasure to be a part of his team. He also impressed me with his knowledge of clinical operations, ICH-GCP and risk management. I learned a lot from working together with Danilo and would welcome the chance to do so again in the future.
Marija Pesic
Danilo and I worked together on a number of clinical trials ( from small Phase 1 to large Phase 3) which Danilo led operationally. He is experienced and self motivating lead who is not only an excellent problem solver but is actually proactively able to to anticipate and prevent issues before they happen. He is a great team player with ability to lead large cross-functional teams in a collaborative spirit. Moreover, he is always ready to do the extra mile, which is often needed to push the project forward in a timely manner. I hope we work together on more projects in the future!
Michael Joseph Roehl
Danilo was my direct lead when we worked together on a phase III international, randomized trial. In this capacity, he was responsible for Sponsor Oversight of the operational CRO. His organized and transparent style of leadership made it easy and a pleasure to be a part of his team. He also impressed me with his knowledge of clinical operations, ICH-GCP and risk management. I learned a lot from working together with Danilo and would welcome the chance to do so again in the future.
Marija Pesic
Danilo and I worked together on a number of clinical trials ( from small Phase 1 to large Phase 3) which Danilo led operationally. He is experienced and self motivating lead who is not only an excellent problem solver but is actually proactively able to to anticipate and prevent issues before they happen. He is a great team player with ability to lead large cross-functional teams in a collaborative spirit. Moreover, he is always ready to do the extra mile, which is often needed to push the project forward in a timely manner. I hope we work together on more projects in the future!
Michael Joseph Roehl
Danilo was my direct lead when we worked together on a phase III international, randomized trial. In this capacity, he was responsible for Sponsor Oversight of the operational CRO. His organized and transparent style of leadership made it easy and a pleasure to be a part of his team. He also impressed me with his knowledge of clinical operations, ICH-GCP and risk management. I learned a lot from working together with Danilo and would welcome the chance to do so again in the future.
Marija Pesic
Danilo and I worked together on a number of clinical trials ( from small Phase 1 to large Phase 3) which Danilo led operationally. He is experienced and self motivating lead who is not only an excellent problem solver but is actually proactively able to to anticipate and prevent issues before they happen. He is a great team player with ability to lead large cross-functional teams in a collaborative spirit. Moreover, he is always ready to do the extra mile, which is often needed to push the project forward in a timely manner. I hope we work together on more projects in the future!
Credentials
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Project Management Professional (PMP)®
The Project Management Institute (PMI)Dec, 2015- Nov, 2024 -
Regulatory Affairs Certification (RAC)
Regulatory Affairs Professionals Society (RAPS)Sep, 2021- Nov, 2024
Experience
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PAION AG
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Germany
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head Sponsor Oversight
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Jan 2019 - Present
Phase I to Phase III anaesthesia trials, general and procedural sedation, paediatrics and adults Hypotension, Schock paediatric trials Setting up Sponsor Oversight department and processes Risk Management (KRIs, QTLs)Vendor selection and management, Budget managementInspection readiness (FDA), audits Management of co-monitoringKPIs Phase I to Phase III anaesthesia trials, general and procedural sedation, paediatrics and adults Hypotension, Schock paediatric trials Setting up Sponsor Oversight department and processes Risk Management (KRIs, QTLs)Vendor selection and management, Budget managementInspection readiness (FDA), audits Management of co-monitoringKPIs
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Freelance Clinical Consultant
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Dec 2017 - Dec 2018
Risk management and sponsor oversight Trial Management and oversight of clinical trials Control of scope, schedule, cost and quality including the change managementClinical operations ( from feasibility until close-out) Creation and review of key clinical documents (protocol, plans, ICFs....)Vendor selection and oversight (Co)Monitoring, sponsor oversight visits CRO selection and management, training of key personnelRisk identification and planning Risk management and sponsor oversight Trial Management and oversight of clinical trials Control of scope, schedule, cost and quality including the change managementClinical operations ( from feasibility until close-out) Creation and review of key clinical documents (protocol, plans, ICFs....)Vendor selection and oversight (Co)Monitoring, sponsor oversight visits CRO selection and management, training of key personnelRisk identification and planning
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Phortas
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Germany
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Consultant
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Dec 2017 - Dec 2018
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PAION AG
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Germany
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Trial Lead
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Jan 2017 - Nov 2017
Phase III General Anesthesia EU Procedural sedation:Phase III Study (Colonoscopy) USAPhase III ASA 3 & 4 patients Colonoscopy USAPhase III Study (Bronchoscopy) USALeading the global cross functional project team of large Phase III pivotal registration studies to meet all project requirements and contribute to the company’s strategic goals.
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Clinical Project Manager
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Mar 2015 - Dec 2016
Phase III General Anesthesia (Cardiac Surgery) trial EUProcedural sedation:Phase III Study (Colonoscopy) USAPhase III ASA 3 & 4 patients Colonoscopy USAPhase III Study (Bronchoscopy) USASome of responsibilities: Sponsor oversight visits. Vendor selection and oversight. Control of scope, schedule, cost and quality including the change management. Country and site selection, site performance management. Risk identification and planning of risk responses. Creation of trial specific guidelines and manuals.
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Grünenthal Group
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Germany
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Pharmaceutical Manufacturing
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700 & Above Employee
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Global Operations Study Manager (GOSM)
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Apr 2013 - Feb 2015
Phase III multinational multicenter trials:Pediatric acute pain trial (in cooperation with Janssen - Johnson & Johnson)Pediatric chronic pain trialPostoperative neuropathic pain trial
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GSA (Global Study Associate)
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Jan 2012 - Mar 2013
Phase IIIb Cancer pain trial - Inspection preparation initiative, review of TMF, Coordination and cooperation with different vendors (Local and central Depots, IxRS), IMP reconciliation on Study level , support during "Quality control" site visits.
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Argint International (now Precision for Medicine)
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Hungary
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Research Associate
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Jul 2010 - Sep 2010
Phase IIb Study in Neurology (RR-MS) Phase IIb Study in Neurology (RR-MS)
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Accelsiors CRO
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Switzerland
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Biotechnology Research
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100 - 200 Employee
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Clinical Research Associate
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Nov 2009 - Jun 2010
• Phase III Study in Oncology (breast cancer) • Phase III Study in Endocrinology(growth hormone)
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Quality Assurance Associate
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Aug 2008 - Oct 2009
• Participation as a member of the Quality Assurance Unit in implementation of Good Clinical Practices (GCP).• Understanding international and local requirements including: EU Directives, FDA standards, ICH - GCP requirements and national law.• Development and maintenance of Standard Operating Procedures (SOPs) and Work Specific Instructions (WSIs).
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Education
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2002 - 2008
University of Novi Sad,Faculty of Medicine, Department of Pharmacy, Serbia.
MSc, Pharmacy
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