Marcus Stewart-CV
Marcus Stewart
------------ ------------
PROFESSIONAL SUMMARY
Bright, outgoing, pro-active individual with keen interest in pursuing a career in Business. Natural leader that works well with a team and a skilled ability to build trust with others. Quick learner with a proven ability to deliver results. Experienced in professional and customer service-based environments. Pragmatic, composed, creative, and powerful when given room to expand. Exceptional ability to manage and communicate. Honest and trustworthy individual with a strong business acumen.
SKILLS
? Sales and POS software
? Verbal and written communication
? Knowledge of GCPs
? Public speaking
? Attention to detail
? Time management
? Protocol development
? Team player
? Basic clinical research
? Microsoft Office systems
? Veeva Vault
? eMTF
? iMediadata
? LiveLink
RELEVANT EXPERIENCE
Exelixis, Alameda, CA - Clinical Operations Specialist/TMF Manager October 2018 - May 2019
? Managed processes and procedures for filing, retrieving, storing, preserving, and protecting of clinical records and collaborated with other departments where such procedures/processes overlap.
? Helped to establish a quality oversight process for the retrieval and processing of Clinical Records.
? Conducted facilities planning by reviewing short- and long-term resource and space requirements to identify and evaluate possible options for on and off-site locations.
? Collaborated with functional groups within the company to develop, implement and maintain a disaster preparedness and business continuity program.
? Knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
? Ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
Cruise Automation, San Francisco, CA - Automated Vehicle Trainer August 2018- October 2018
? Collaborated closely between the software and hardware engineers as well as software operations specialists to advance the companies technologies and internal workflows, and ultimately help shape the product roadmap.
? Assist researchers and engineers to implement/support the development of algorithms for autonomous driving.
? Utilize proprietary software to gather data and troubleshoot in a variety of real world situations, while simultaneously providing detailed and accurate feedback to our engineers.
? Assisted engineers and team members in migrating research code to operate on test and production systems.
? Learned to troubleshoot systems in real time and how to diagnose multiple problems within the software, while under pressure or in extreme situations.
? Reviewing software code to diagnose problems the hardware may or may not encounter.
Tech & Health Organization, Oakland, CA - Intern October 2017 - December 2017
? Responsible for researching data and preparing reviews on articles that would allow the team to properly present their ideas during board meetings.
? Assisted the team in developing a location database for a new application. Involved reaching out to multiple organizations to see if they fit the guidelines of the app.
? Provided detailed transcriptions of focus group dialogue.
BioMarin Pharmaceuticals, San Rafael, CA - Data Management Assistant/TMF Administrator
June 2015 -July 2016
? Tracked progress of the individual trials, and own personal progress, using Excel spreadsheets
? Participated in biometrics systems User Acceptance Testing (UAT) for new trial development.
? Usage of GCP and GLP regulations associated with the maintenance and retention of clinical trial documentation and pre-clinical study records.
? Quality checks on both electronic and paper documents submitted to the records room and within the CTMS
? Managed a TMF Content list and TMF comprehensive review tracker.
? Fulfilled customer requests for retrieval, reproduction, and
re-filing of records or their electronic copies (pdf).
? Scanned, filed, sorted, separated, photocopied, printed, indexed, and
distributed both labels and files, of a variety of clinical study
records/documents in accordance with SOP mandated timelines.
? Supported inspection and audit preparation activities by providing access to documents across multiple sites, while keeping track of what department had them, as well as when and where they should
be returned.
? Assisted with the identification and correction of errors for
documents within the VeevaVault system before FDA inspections.
? Maintained an efficient system for storing documents both internally and externally. Strong communication line to
offsite locations & personnel
Additional experience includes: Abercrombie & Fitch, Tilly’s, The Cheesecake Factory, Wine Bar
EDUCATION
Columbia University, New York, NY - Bachelor's Degree Present
Business and Psychology major
Berkeley City College, Berkeley, CA - Associate’s Degree August 2016 - December 2018
Business Administration
Marcus Stewart
------------ ------------
PROFESSIONAL SUMMARY
Bright, outgoing, pro-active individual with keen interest in pursuing a career in Business. Natural leader that works well with a team and a skilled ability to build trust with others. Quick learner with a proven ability to deliver results. Experienced in professional and customer service-based environments. Pragmatic, composed, creative, and powerful when given room to expand. Exceptional ability to manage and communicate. Honest and trustworthy individual with a strong business acumen.
SKILLS
? Sales and POS software
? Verbal and written communication
? Knowledge of GCPs
? Public speaking
? Attention to detail
? Time management
? Protocol development
? Team player
? Basic clinical research
? Microsoft Office systems
? Veeva Vault
? eMTF
? iMediadata
? LiveLink
RELEVANT EXPERIENCE
Exelixis, Alameda, CA - Clinical Operations Specialist/TMF Manager October 2018 - May 2019
? Managed processes and procedures for filing, retrieving, storing, preserving, and protecting of clinical records and collaborated with other departments where such procedures/processes overlap.
? Helped to establish a quality oversight process for the retrieval and processing of Clinical Records.
? Conducted facilities planning by reviewing short- and long-term resource and space requirements to identify and evaluate possible options for on and off-site locations.
? Collaborated with functional groups within the company to develop, implement and maintain a disaster preparedness and business continuity program.
? Knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
? Ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
Cruise Automation, San Francisco, CA - Automated Vehicle Trainer August 2018- October 2018
? Collaborated closely between the software and hardware engineers as well as software operations specialists to advance the companies technologies and internal workflows, and ultimately help shape the product roadmap.
? Assist researchers and engineers to implement/support the development of algorithms for autonomous driving.
? Utilize proprietary software to gather data and troubleshoot in a variety of real world situations, while simultaneously providing detailed and accurate feedback to our engineers.
? Assisted engineers and team members in migrating research code to operate on test and production systems.
? Learned to troubleshoot systems in real time and how to diagnose multiple problems within the software, while under pressure or in extreme situations.
? Reviewing software code to diagnose problems the hardware may or may not encounter.
Tech & Health Organization, Oakland, CA - Intern October 2017 - December 2017
? Responsible for researching data and preparing reviews on articles that would allow the team to properly present their ideas during board meetings.
? Assisted the team in developing a location database for a new application. Involved reaching out to multiple organizations to see if they fit the guidelines of the app.
? Provided detailed transcriptions of focus group dialogue.
BioMarin Pharmaceuticals, San Rafael, CA - Data Management Assistant/TMF Administrator
June 2015 -July 2016
? Tracked progress of the individual trials, and own personal progress, using Excel spreadsheets
? Participated in biometrics systems User Acceptance Testing (UAT) for new trial development.
? Usage of GCP and GLP regulations associated with the maintenance and retention of clinical trial documentation and pre-clinical study records.
? Quality checks on both electronic and paper documents submitted to the records room and within the CTMS
? Managed a TMF Content list and TMF comprehensive review tracker.
? Fulfilled customer requests for retrieval, reproduction, and
re-filing of records or their electronic copies (pdf).
? Scanned, filed, sorted, separated, photocopied, printed, indexed, and
distributed both labels and files, of a variety of clinical study
records/documents in accordance with SOP mandated timelines.
? Supported inspection and audit preparation activities by providing access to documents across multiple sites, while keeping track of what department had them, as well as when and where they should
be returned.
? Assisted with the identification and correction of errors for
documents within the VeevaVault system before FDA inspections.
? Maintained an efficient system for storing documents both internally and externally. Strong communication line to
offsite locations & personnel
Additional experience includes: Abercrombie & Fitch, Tilly’s, The Cheesecake Factory, Wine Bar
EDUCATION
Columbia University, New York, NY - Bachelor's Degree Present
Business and Psychology major
Berkeley City College, Berkeley, CA - Associate’s Degree August 2016 - December 2018
Business Administration