SCOPUS research CRO

SCOPUS research CRO

מומחה לניהול ניסויים קליניים

מודיעין מכבים רעות, Israel
Freelancer

ABOUT

Since 2007 in Clinical Research environment. Has strong background in clinical monitoring, experienced in all aspects of project phases from site selection to close-out in multi-center studies and community studies in Oncology - Breast, Oncology Pancreas, Oncology-Pediatric, Oncology - Follicular lymphoma, Oncology - colorectal Gastroenterology, Oncology – lung Neurologic, Psychiatric, Hepatic, Cardiology, Diabetes studies, Orthopedic, Rheumatology and other therapeutic areas.

LANGUAGES

Russian
Native or bilingual proficiency
English
Full professional proficiency
Hebrew
Full professional proficiency

SKILL DETAILS

Sales & Marketing

185 ₪ / hr
Research & Surveys
Since 2007 in Clinical Research environment. Has strong background in clinical monitoring, experienced in all aspects of project phases from site selection to close-out in multi-center studies and community studies in Oncology - Breast, Oncology Pancreas, Oncology-Pediatric, Oncology - Follicular lymphoma, Oncology - colorectal Gastroenterology, Oncology – lung Neurologic, Psychiatric, Hepatic, Cardiology, Diabetes studies, Orthopedic, Rheumatology and other therapeutic areas.

EMPLOYMENT HISTORY

June 2017 - Today

Freelancer Clinical Research Specialist

Scopus research, Modiin
  • Trial and site management.
  • Start up activities from feasibility to regulatory submission and site regulatory approval.
  • Site Initiation and activation.
  • Site monitoring and ongoing study management per sponsor requirements.
  • Site staff training.
  • Ongoing regulatory support for updated study documents and regulatory documents review.
  • IP accountability and reconciliation. IP management of supply, receipt and destruction.
  • Inspection Ready guidelines to site and sponsor.
  • Vendor management, EDC, IWRS, Lab.
  • Budget and site contracting.
2016 - 2017

Director of Clinical Operations

Galmed Pharmaceuticals, Tel Aviv
  • Reports to VP clinical operations. Oversight of all clinical trials conducted globally under GalMed. Oversee regional CPMs and report global project Management status to VP clinical operations. Oversee regional CPMs on regulatory and start up activities of all clinical trials conducted under Galmed. Perform employee assessments to direct reports and oversee employee assessments performed by regional CPMs. Support regional CPMs in employee recruitment and training. CRO Selection and Management. CRO periodic review. Global vendor Selection and Management. Review Vendor contracts, and contract renewal process and submit to VP clinical and Director of Legal Department Global oversight on Data Management vendors, and internal insight employees and DM activities. Oversee Data base locks and milestones. Global set up of Study systems and ongoing reports. Review study protocols and protocol related documents and amendments. SOPs writing Reports Sr. Medical Director global safety set up and ongoing oversight of safety activities during study execution, with accordance to Sr. Medical Director guidelines. Review project finance on a global level and submit to VP clinical and Director of Finance for final review and approval. Support regional CPMs in site selection. Support VP clinical operations on ongoing projects, or any other activities.
November 2015 - July 2016

Clinical Project Manager (EU, EEU, Asia)

Galmed Pharmaceuticals
  • Overall responsibility for all Galmed clinical Trials running in region Protocol converting according to GCP Requirements Vendors selection in the regions Study Sturt up, submissions, regulatory requirements follow up, study tools creation, overview on site performance. Management of study budgets: vendors, investigators, sites Contracts execution assistance Management of staff – CRAs and CTAs
March 2015 - March 2016

Sr. CRA

Galmed Pharmaceuticals
  • Study start up, Site selection Overview on site creation and regulatory follow up Submissions Study management to include site monitoring Quality data management uploaded to CRF, TMF Queries resolution
March 2011 - February 2015

Sr. CRA

Quintiles
  • Study start up, Site selection Overview on site creation and regulatory follow up Submissions Study management to include site monitoring Quality data management uploaded to CRF, TMF Queries resolution

1 SKILLS

185 ₪ / hr

Sales & Marketing

Research & Surveys