Samanta Andrea Bazan

Personal information

• Address: Argerich 5871 Floor 2, apart. D, Capital Federal, City of Buenos Aires

• Mobile phone: +54 9-11-586*****

• Date of birth: 17 April 1982

• Email: adlg9s@r.postjobfree.com

Education

Bachelor s degree: Nature sciences with animal systematics and morphology orientation (Biologist). Graduated from the University of Buenos Aires in 2009. Work history

Translator position - Piumadi Diseños Integrales S.A. - From January 2006 to October 2008

Translation of different types of document. Translation of signages and posters in Melia Hotel located in Recoleta Neighborhood

Translator position – Vertebrates Laboratory of the University of Buenos Aires - From October 2008 to December 2009

Translation of scientific papers published in different science magazines Sales documents Manager – Caladero Argentino S.A. – From December 2009 to September 2014

Translation of different types of sales documents, contracts and bulletins. Preparation of import and export documents (as Bill of lading) . Follow up pf drafts. Follow up of Health Authority documents. Participate as trader in buying and selling frozen fish products. Represent the company in different conferences and trade shows across the globe

Data analyst CPO project (Country Pharmaceutical Organization) – Pharmacovigilance

– Cognizant Technology Solutions - Novartis Laboratory – From September 2014 to June 2017

Responsible for detect, collect, monitor, research, assess and evaluate information of adverse events with pharmaceutical medications. Revision of source documents. Responsible for data entry, MedDRA coding and label assessment of adverse event. Provide a detailed narrative of the cases. Send the correct cases to the pertinent health authority of each country. Responsible for internal quality. Follow up of queries with different countries. Identify and analyze causes for the different queries and issues and suggest preventive and corrective actions. Mentor of new hires. Responsible for providing daily training to new hires. Responsible of Minutes of meetings confection. Point of contact responsible of providing new information to the team.

Senior Clinical Data Manager/Analyst – PRA Health Sciences – Merck Laboratory – From June 2017 to December 2019

Responsible for Running and Comparing reports from Cognos and J-Review platforms with a comparator tool. Run Ad Hoc reports when required and needed. Run listings of discrepancies obtained in DMW platform. Revise discrepancies and issue manual and system queries using different query wordings and validation check. Review clinical and external data for subjects enrolled in clinical research protocols based on edit specifications / data validation programs to facilitate data review. Review data in Inform Data Base Platform and revise edit checks (auto queries in Inform Data Base), validation checks

(obtained from DMW) and outputs from different reports (obtained from Cognos and J-Review platforms). Manage the data review and external data reconciliation process. Able to revise data and determine when a query should be issued. Manage timelines for queries revision. Participate in Start-Up and In-Life activities providing support to the Lead Clinical Data Coordinator in the creation and update of Data Entry Guidelines document, the creation and update of Data Validation Plan document and updates of reports, Edit Checks and Validation checks. Maintain fluent communication with Programmers, Trial Manager and Lead site Monitors among others when required. Perform eTMF Reconciliation. Maintain data management study documentation as appropriate such as updates and confection of Job Aids, data Entry Guidelines, Protocols to provide support for the different reports and to facilitate the revision of the data for the new joiners of a clinical study. Mentor and train other team members in data management skills and processes for individual studies. Mentor of New Hires, Clinical Data Managers (CDM) and trainee Clinical Data Managers. Mentor and train multiple Senior Clinical Data Coordinators for study Start-Up, maintenance, and closeout. System experience in Oracle Inform 4.6 and 6.1 (PDAM NG), J-Review, DMW, Veeva Vault eTMF and Interactive Response Technology (IRT) System. Responsible for the high quality in data management tasks. Lead Clinical Data Manager/Analyst – PRA Health Sciences – Otsuka Laboratory – From December 2019 to present

Responsible for running listing reports from eSource and J-Review Platforms. Participate in different studies from UAT to Data Base Lock. Testing of different validation checks. Assure Clarity, Precision and Safety of clinical data. Review and revision of protocols, Completion Guidelines documents, eCRFs as other type of documents. Review clinical and external data for subjects enrolled in clinical research protocols. Manage timelines for queries revision. Responsible of providing a full manual review of clinical data

Skills

• Active listening

• Effective Communication

• Interpersonal skills

• Leadership

• Management skills

• Problem-solving

• Adaptability

• Willingness to learn

• Organization

• Teamwork

• Creativity

• Flexibility

• Multitasking

• Intrinsic motivation

• Collaborative

Knowledges

• Oracle Inform 4.6 and 6.1 (PDAM NG)

• J-Review

• DMW

• Veeva Vault eTMF

• Interactive Response Technology (IRT) System

• eSource (from different vendors)

Other courses

• Microsoft Office

• Frozen fish traceability and production

• Introduction to foreign commerce

• Quality control training in frozen fish and line production in land and vessels (foreign commerce)

• Investigational methodology and Clinical study monitoring (CRA). Certificate issued by the Austral University

Languages

• Spanish: Native

• Ingles: advance level

• Mandarin Chinese: Intermediate level

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