Travis Brown

Experience

• 

  Dignity Health

  Aug 2004 - Aug 2006

  Pathology Laboratory Technician
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  Dignity Health

  Jun 2007 - Jan 2009

  Clinical Laboratory Assistant
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  Quantum Marketing

  Jan 2010 - Mar 2011

  Team Leader
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  Procter & Gamble

  May 2011 - Apr 2012

  Research Associate
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  Gilead Sciences

  Jul 2012 - now

  Established leader within the Early Phase CDM space. Conducts performance management and mentorship of junior and senior clinical data manager direct reports. Specific responsibilities include:- Leads and provides oversight for the execution of data management activities at the project level (for a product or multiple studies within an indication), demonstrating knowledge of hands-on work- Serves as lead on complex studies where necessary- Accountable for departmental infrastructure project deliverables- Participates in CDM organizational improvement discussions and cross-functional initiative teams- Consultant to to study management teams with respect to data management risks and issue management- Ensures completeness/accuracy/consistency of clinical data and data structure across all projects- Trains staff on business processes and clinical programs- Participates in development, review, and implementation of policies, SOPs and associated documents affecting CDM- Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.- Support of regulatory submission activities for assigned projects- Assist with response to findings from Clinical Quality Assurance (CQA) and other audits at the study/vendor level- Communicates with functional peers regarding project status and issues and ensure project team goals are met- Participates in recruiting and hiring for CDAs and support their professional development- Provides guidance and training to CROs, vendors, investigators, and study coordinators on study requirements- Working knowledge and experience with FDA/EMA regulations and industry wide thesauri, such as MedDRA- Anticipates internal resource needs and external costs for the short and long term. Works with senior management and HR to ensure long-term resource allocation within a therapeutic area- Works within budget constraints while being fiscally responsible and utilizing resources efficiently Show less * Independently leads multiple complex studies simultaneously* Serves as point of contact for study management team (SMT) and interacts effectively within cross-functional team* Identifies, tracks, and resolves all queries and issues, including those raised by Clinical Research, with ample time to communicate escalation issues for effective data validation* Reviews study protocols and assists site staff and investigators to collect protocol-required data in a timely manner. Serves as site and team lead for data management activities* Presents standards to senior leadership team to increase Phase 1 team efficiencies as a member of the biometrics standards initiative. Applies expertise to implement department-level updates for all therapeutic area standards* Mentors junior CDMAs by explaining CDM processes and coaching on effective communication strategies with SMT and vendor interactions* Communicates CDM processes and implications involved in process deviation to vendors and SMT* Presents on CDM projects as Phase 1 representative to align department goals with Phase 1 processes, specifically surrounding CDM project timelines, ECG data transfers, and standards* Facilitates QT data transfer standardization project to align later-phase studies with phase 1 for ECG and TQT data, specifically oriented towards regulatory agency submissions* Delegates where appropriate to execute study deliverables within operations’ timelines* Utilizes effective project management to prioritize tasks on submission critical pathways* Organizes, maintains, and reviews all study trial master files (TMF) to meet regulatory requirements Show less

  • Manager, Clinical Data Management

    Mar 2022 - now

  • Clinical Data Management Project Lead

    Sept 2017 - Mar 2022

  • Senior Clinical Data Management Associate

    Feb 2017 - Mar 2022

  • Clinical Data Management Associate II

    Jan 2015 - Jan 2017

  • Clinical Data Associate I

    Jul 2012 - Jan 2015