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Dynamic clinical operations professional with experience in both translational pharmaceutical research and clinical trial management. Experience primarily lies in the fields of oncology and pain medicine. Excels in fast paced, high complexity environments. Holds a B.S. in Biological Sciences with focus on molecular and cell biology.Protocol Development and Implementation | Global Clinical Trial Management, Phase I, II, III | Budget Development and Management | Good Clinical Practice (GCP), 21 CFR, and ICH guidelines
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Clinical Operations LeadGenentech Aug 2022 - PresentSouth San Francisco, California, Us● Oversees global operations for late stage drug development● Managed feasibility for multi-center global COPD study, ARNASA, with a focus on identifying trial sites with diverse patient populations● Develops global recruitment strategies for accelerated, high priority studies ● Hosts recruitment workshops for high priority study nationally to identify and address barriers to enrollment● Oversees multiple third party vendors and ensures accountability in spending -
Senior Clinical Trial AssociateIgm Biosciences, Inc. Nov 2021 - Aug 2022Mountain View, California, Us -
Project ManagerTeneobio, Inc. Feb 2021 - Oct 2021● Developed project timelines and identified critical paths through coordination between different teams, including nonclinical, CMC, regulatory, and finance ● Coordinated study start up for first-in-human phase I global trials● Developed processes for change management and lessons learned review to continually improve department efficiency● Oversaw completion of all regular filings with FDA and relevant regulatory agencies
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Research AssistantAnabios Corporation Dec 2019 - Feb 2021San Diego, Ca, Us● Contributed to writing IND-enabling reports on behalf of sponsors ● Collaborated directly with clients and Sponsors to identify key project management timelines and goals● Provided crucial data for the creation of clinical development plans● Designs and implements experimental protocols utilizing calcium imaging techniques● Conceptualizes and validates in vitro models of pain and inflammation based on recent scientific literature● Co-authors scientific manuscripts based on experimental findings -
Clinical Research Project ManagerVitamed Research Jun 2019 - Feb 2021● Transformed a one-person department into a multi-functional contract research organization● Managed inter-departmental team while maintaining effective and clear communication● Executed contract and budget negotiations with Sponsors● Led protocol, ICF and CRF development on behalf of Sponsors● Planned and performed regular internal audits of data and documentation, including TMFs -
Clinical Research CoordinatorVitamed Research Apr 2018 - Jun 2019● Participated in site initiation visits and meticulously completed all relevant documentation, including training documents and 1572s● Worked under Principal Investigator to manage all clinical trials at site● Led all site recruitment and retention efforts● Adhered to Good Clinical Practices (GCP), ICH guidelines, and 21 CFR● Conducted medical device, pharmaceutical, and observational studies
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Research InternUc Santa Barbara Jun 2009 - Jul 2009Santa Barbara, Ca, Us● Worked for a professor in a graduate level Biochemistry laboratory● Contributed to the creation of a field test for gamma hydroxybutyric acid (date rape drug) in alcoholic beverages● Worked with many different laboratory procedures, particularly mass spectrophotometry of the action of related enzymes● Wrote a formal lab report, detailing all procedures and results, as well as areas for future research
Chloe Hughes Skills
Chloe Hughes Education Details
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University Of California, BerkeleyGeneral
Frequently Asked Questions about Chloe Hughes
What company does Chloe Hughes work for?
Chloe Hughes works for Genentech
What is Chloe Hughes's role at the current company?
Chloe Hughes's current role is Clinical Operations Lead.
What is Chloe Hughes's email address?
Chloe Hughes's email address is ch****@****ios.com
What is Chloe Hughes's direct phone number?
Chloe Hughes's direct phone number is +180525*****
What schools did Chloe Hughes attend?
Chloe Hughes attended University Of California, Berkeley.
What skills is Chloe Hughes known for?
Chloe Hughes has skills like Social Media, Public Speaking, Microsoft Office, Microsoft Excel, Powerpoint, Microsoft Word, Facebook, Laboratory, Research, Social Media Marketing, Management, Photoshop.
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