Senior Clinical Trials Manager, Teva
2015-Current: TEVA- Senior Clinical Trials Manager
• Global clinical trial management-
• Country management, selection, recruitment, training and development.
• Planning and feasibility assessments of projects.
• Cross function integration -business infrastructure, data management and medical affairs, etc.
• Review and selection of outsourcing providers for clinical trials. Execution and maintenance of multiple vendors and outsourcing strategy
• Supervision on project's progress, timelines, cost and quality management
• Support to Project management in achieving project deliverables within scope, budget and timelines. Acts as source of knowledge and expertise on country specific practices and regulations.
2014- 2015: Immune Pharmaceuticals- Clinical Operations Manager
• Planning and managing local and global clinical trials.
• Study startup planning and activities (Site selection, negotiation, initiation).
• Selection, negotiation, management and supervision of all study vendors including outsourced CRO’s and CRA’s
• Managing and overseeing operational aspects, including clinical activities, protocol planning, patient care, and resources distribution, business activities, and overseeing and coordinating project teams.
• Establish timelines, goals, and objectives. Coordination of multidisciplinary teams to ensure both timeliness and accuracy of studies.
• Clinical writing and documents origination (protocols, amendments, CRF, informed consent forms etc.).
• Budget planning and execution
• Regulatory compliance- submissions, preparation, communication with authorities, IRBs and KOLs worldwide.
• Strategic advice and direction to other departments.
2010- 2013 BioLineRX: Project Manager/ Senior Clinical Research Associate
• Management and startup of clinical studies in Israel, US and EU
• Documents originations, writing and planning.
• Management of clinical sites, CROs and CRAs worldwide
• Pharmacovigilance activities and reporting
• Budget overview
• Communication and collaboration with team members and colleagues worldwide
• Organization and participation in scientific advisory meeting, investigator and site selection, organization and participation in investigator meetings, vendor selection, participation and organization of site initiations, organization of study shipments.
• Regulatory process of different regulatory authorities and ethic committee's worldwide (Israel, US, Europe and other countries)
• Preparation and submissions to EC and local authorities (Israel, US, Europe and other countries)
• Management and fulfillment of study activities- overseeing patient recruitment, adherence to local regulation and study requirements, verifying study supplies, monitoring
• Clinical site monitoring: Source data/document verification (SDV), coordination of shipments (study drugs and biological samples)
• Coordination between the sponsor requirements, investigators and vendors
• Oversight on of external suppliers- CRO, Data Management, IVRS, blinded reviewer and video editor in order to ensure completion of tasks in accordance to timelines and budget
• Study Closure- query resolution, site closures, contract finalization, reviewing and editing of CSR, notification of regulatory authorities
• Clinical documentation coordinator- managing all clinical documents and archiving
2010 Novartis pharm clinical: CTA
• Interaction and coordination with sponsors, SC, Sites, Vendors
• Corresponding and interfacing with regulatory organization, including ECs and hospitals departments
• Preparation and submission of applications and all related documentation to the Ethical Committee and local health authorities, revision of regulatory documents.
• Clinical interactive systems.
• Product inventory and accountability and shipment
• IP ordering and transportation
• Revision and reviewing of data and documents
2008-2010 QBI Enterprises (Quark pharmaceuticals)
• Preclinical Data base appointee- responsible for all data collection, processing and analyzes
• Eye micromanipulation- Retina Model in Rats and mice
• In Vivo unit – animal modeling in rats and mice:
• Brain and spinal cord operation
• Lungs and kidneys Injury- Knockdown and Efficacy testing
• Tumor Neovascularization methods
• Pre clinical drag testing by- intratracheal, intradermal, intrapretoneum
• In vitro unit- siRNA development, structure and analyzing methods
2001-2007- Hadassah Hospital Jerusalem
Hepatitis and hepatic cirrhosis modeling and anticirrosis drugs screening on mice and other small animals: organs isolation, blood sampling from caudal vein, heart, and eye.
Primary cell culture establishing and maintenance.
Cardiology Department Heart research on animals (mice, rats, rabbits and pigs). Ischemic models, evaluations of effects, open chest operations, immunofluorescent staining
Transgenic Animals) - Animal eggs production, hormone injections, animal maintenance, participation in stem cells projects
Anatomy Department -Co project with Prof. Zina Ben-Ishay and Prof. Vivian Barak: Anti- angiogenic effects of VEGF on localized murine tumors progression. Operations on mice, leukemia cell isolation, tumor formation and implantation, drugs injections, bone marrow production, immunochemical staining, microphotography
Oncology Laboratories– General assistance in research including protein isolation and analyses, column chromatography, cell culture maintenance
2011- 2013- M.Sc. Managements of High Technology. Holon institute of Technology
2003- 2007- B.Sc. Faculty of Life Science. Open University Jerusalem
2005 -Animal Facility Courses at Hebrew University with authorized entrance to SPF
(Rodents and large animals).
2010 - CRA (Pharma job) -monitoring course
GCP- (Bioforum) - good clinical practice course
CRF design (Bioforum)
2011- MedDRA- (Bioforum) Data tracking and classification
2012- Technical and Medical writing- AMWA
2016- IND & NDA submission for drug & biologics in the US and EU
Hebrew- mother tongue
Russian- mother tongue