Maria Ruiz Email and Phone Number
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Clinical Scientist with experience in protocol development and execution. Highly experienced in clinical monitoring and regulatory agency responses. Proven ability to work independently or as member of top performing team.
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Global Studies ManagerGenentech Jul 2021 - Present -
Expert Global Trial ManagerNovartis Apr 2018 - Jul 2021East Hanover, NjAuthor clinical trial protocols and ICFs for Global Phase III Oncology patient studiesSupport Global Trial Director in study start up for Global Phase II/III Oncology patient studies, including country feasibility, study budget, drug supply, HA/EC submission, vendor management, clinical trial database setup, investigator and CRA protocol training, and steering committee initiationMonitor patient enrollment, lead Clinical Trial Team meetings, lead Data Review Team meetings, conduct clinical data review and provide safety updates to program medical lead for Global Oncology clinical trialsCTT lead for Phase II/III studies and responsible for all aspects of study start upResponsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned. -
Senior Clinical ManagerNovartis Oct 2015 - Apr 2018East Hanover, NjEnsure all trial deliverables are met per timelines, budget, operational/clinical and quality standard• Tracked patients, reviewed clinical data, and collaborated with CTH and medical lead on meetings and trial issues.• Contributed to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.• Managed of study vendors and ensured adherence to scope of work within timelines and budget for the study.• Reported trial information in all trial databases and tracking systems with accuracy• Supported IRB requests by collaborating with medical lead and statistician as necessary.• Chaired team meetings (CTT, DRT, ad-hoc) and drafted minutes for distribution• Responsible for compiling Investigator Brochure, organized meetings and provided guidance to contributors.
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Clinical ScientistMerck & Co., Inc. Jan 2007 - Oct 2015Supported program planning in Phase III to Phase V clinical studies.• Authored protocols; assisted in committee reviews to improve content• Led protocol through initiation, maintenance and close-out• Provided clinical representation at diverse teams and meetings• Initial clinical point of contact for scientific issues• Worked closely with Clinical Monitor to ensure accuracy and safety objectives were met during trials.• Reviewed/approved documents including informed consent risk language, laboratory specifications, laboratory budgets, etc• Interacted with contract research organization (CRO) for trial execution.• Performed medical monitoring with the team• Plan and collaboratively author clinical study reports (CSR)• Develop case narratives for serious adverse events (SAEs)• Receive reportable events (SAE/Pregnancies) for submission to regulatory agencies• Create and process safety queries to resolve any discrepancies with safety data• Interacted with sites and country monitors on study questions, protocol deviations and any clinical questions -
Data Management SpecialistMerck Dec 2000 - Jan 2007Rahway, NjSupported data management activities in phase II to phase V for clinical studies.•Interfaced with cross-functional groups to ensure accuracy and completeness of clinical database•Used manual and automated methods to perform data review to ensure integrity and consistency of clinical data•Interacted with sites and clinical teams for data discrepancy resolution
Maria Ruiz Skills
Maria Ruiz Education Details
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Biology, General -
Biology, General
Frequently Asked Questions about Maria Ruiz
What company does Maria Ruiz work for?
Maria Ruiz works for Genentech
What is Maria Ruiz's role at the current company?
Maria Ruiz's current role is Clinical Operations Lead.
What is Maria Ruiz's email address?
Maria Ruiz's email address is ma****@****rck.com
What schools did Maria Ruiz attend?
Maria Ruiz attended Rutgers, The State University Of New Jersey-Newark, Rider University.
What are some of Maria Ruiz's interests?
Maria Ruiz has interest in Working Out, Children, Cooking, Environment, Education, Science And Technology, Human Rights, Animal Welfare, Health.
What skills is Maria Ruiz known for?
Maria Ruiz has skills like Clinical Research, Pharmaceutical Industry, Clinical Trials, Sop, Clinical Development, Gmp, Cardiology, Validation, Diabetes, Protocol Design, Oncology, Protocol.
Who are Maria Ruiz's colleagues?
Maria Ruiz's colleagues are Jennifer Phillips, Matteo Pietra, Jamie Mcadoo, Tatiana Goncharov, Andrea Adams, Doug Demoe, Robert Jordan.
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Maria Ruiz
Trustee Scholar At University Of Southern California I Vice-President Of Latino Students In Law I Questbridge ScholarLos Angeles, Ca -
3ruizfamily.net, excite.com, commonwealthcare.org1 +121280XXXXX
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Maria Ruiz
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Maria Ruiz
Ret. Sr. Vice President Of Sales Development & Training At Wyndham DestinationsOrlando, Fl -
Maria Castillo
Talent Acquisition Specialist | Connecting Top Talent With Exceptional Opportunities | Passionate About Building High-Impact TeamsSan Antonio, Tx
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