Julian Andres Cruz Zarate
Clinical Lead - Clinical Research Manager @Parexel
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WORK HISTORY
Clinical Lead - Clinical Research Manager @Parexel
Montreal, QC, CA
Responsible for project management of the assigned studies at the Country level. Leads local study teams, collaborates with, supports Clinical Research Associates as protocol expert, coordinates activities across the different local country roles.Responsible for creating and executing a local risk management plan for assigned studies, ensuring compliance with Clinical Trial Management Systems and supporting local and regional strategy development consistent with long-term corporate needs in conjunction with Clinical Research Director, Therapeutic Head and Regional Operations.
EDUCATION
Universidad Industrial de Santander
Bachelor's degree, Medical Microbiology and Bacteriology
Universitat de Barcelona
Master's degree, Molecular Biotechnology
Universidad El Bosque
Specialist, Epidemiology
SKILLS
ABOUT JULIAN ANDRES CRUZ ZARATE
Health Care Professional over 8 years working and trained on methodological and conceptual areas as Biotechnology in biomedical areas, pharmaceutical and food industry, environmental applications with knowledge and practice in Genetic Engineering, Biotechnology, Cell and Tissue Engineering, Gene Therapy, Design and Production of Vaccines and Molecular Diagnostic knowledgeable and techniques in management of R + D + I. Skills as researcher and co-investigator in scientific studies. Experience as epidemiological coordinator at surveillance programs. Over 3 years working as Safety specialist Pharmacovigilance on Merck Sharp & Dohme, processing and analyzing data from Clinical Trials sponsored by MSD around the world and assessing causality of adverse events in patients who were at treatment on marketed products, reporting to international regulatory authorities.Past management experience includes leading the oncology franchise team (5 data safety coordinators) at Pharmacovigilance (PV) MSD, co-lead data analysis project, and foster collaboration among franchise teams and across data departments. Improved team productivity by implementing time-tracking and doing weekly SOP overview. More than 2 Year as CRA at IQVIA, Providing monitoring visits, Pharmacy, initiation visit, selection visit and clousure visit on several protocols phase 3 and 4; Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues; Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution; Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation and collaborate with study team members for project execution support as appropriate.
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