Mark Robberson, MBEE

Experience

• 

  Rose Medical Center

  Sept 2012 - Mar 2014

  EMT
• 

  Northglenn Ambulance

  Dec 2013 - Feb 2016

  Paramedic

  .

• 

  North Suburban Medical

  Mar 2016 - Mar 2017

  Paramedic
• 

  DaVita Clinical Research

  Nov 2016 - Aug 2017

  Research Paramedic

  - Assisted in the execution of Phase I clinical studies by completing study procedures such as blood draws, vital signs, ECGs, and dosing of study subjects. - Ensured clinical study quality standards were met through QC and review of source documents. - Trained in GCPs, human subject protection, and clinical trial execution.

• 

  Viridian Therapeutics, Inc.

  Aug 2017 - Nov 2019

  - Independently monitoring and managing clinical sites to meet required quality standards and to support the delivery of studies on schedule and budget. - Managing the collection and execution of all start-up and regulatory documents. - Oversight of the trial master file and study management support. - Managing data cleaning activities for various data cuts to meet regulatory requirements. - Implementing clinical trial and recruitment tracking systems. - Provided clinical trial support through management of trial master files and other administrative tasks for oncology and dermatology trials.- Managed start-up activities for a Phase IIA multi-center clinical trial. - Trained as a clinical trial monitor and began independent monitoring of clinical trial sites. - Implemented tracking systems for clinical trial lab samples.

  • Clinical Research Associate

    Jan 2019 - Nov 2019

  • Clinical Trial Associate

    Aug 2017 - Jan 2019
• 

  Viveve, Inc.

  Nov 2019 - Apr 2021

  Associate Clinical Program Manager

  - Acted as Study Lead for Pivotal Phase clinical trials for a Class III medical device through start-up, enrollment, follow-up, and close out.- Effectively managed vendors including CROs, SMOs, and EDC providers ensuring timelines and budgets were met at all times.- Led contract and budget negotiations for ~30 study sites across the United States and exceeded corporate budget expectations and met tight timelines.- Ensured clinical trial operations and data collection met the highest quality and regulatory standards at all times.- Implemented systems to allow for the successful execution of clinical trials with limited resources. Show less

• 

  Alira Health

  May 2021 - Feb 2022

  Clinical Project Manager

  - Functioned as CRO Study Lead for projects across multiple indications and modalities including being responsible for all study activities from study start-up through close out. - Provided leadership for a multi-disciplinary study team including CRAs, In-house CRAs, Clinical Assistants, Data Management, and outside vendors. - Prepared and delivered study updates to internal and external stakeholders, including client study teams, client executives, and internal management. - Identified issues and implemented problem-solving strategies to ensure study timelines and budgets were maintained.- Oversaw proper training of all study team members to ensure trials were executed in a manner consistent with GCP standards, IRB policies, and FDA regulations. Show less

• 

  Sana Health

  Mar 2022 - now

  - Provides leadership to Clinical Project Managers in management of clinical trials on Sana Health device by proactively managing program and project level operational tasks including but not limited to trial timelines, budgets, resources, and vendors.- Generates and maintains policies and procedures to ensure Sana control of clinical trials to cGCP standards and manages training of Sana team on those clinical policies. - Prepares and delivers internal updates on trial programs to executive level management with respect to project plans, timeline, budgets, quality standards, and regulatory compliance.- Facilitates expert review and oversees the generation, approval, and control of trial documentation, including but not limited to invoices, protocols, and informed consent documentation.- Assists Project Managers in assessing clinical site capabilities, providing guidance and support to clinical sites, and ensuring site compliance with all Sana policies and project plans to ensure the delivery of high-quality clinical data. Show less

  • Vice President of Clinical Operations

    Sept 2023 - now

  • Director of Clinical Operations

    May 2023 - Sept 2023

  • Senior Manager of Clinical Operations

    Mar 2022 - May 2023