Athena Visel, PMP, RQAP-GCP, CCRP, RD
Chief Quality Officer, Principal Consultant at Cliq Solutions, LLC- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Donna M. Stram
She's basically a wizard. In all seriousness, Ms. Thomas-Visel is extremely competent, thorough, accurate and reliable. She is a regular consultant to my company and we highly value her expertise.
Christine Kathan
Working with Athena it became evident she is an exemplary Clinical Quality Assurance Professional. She is highly knowable and experienced in Good Clinical Practice. Proficiency in leading others to a higher level of compliance is a skill she excels at. Her leadership and guidance in Auditing, Good Clinical Practice, Good Documentation Practice and ICH Guidelines laid groundwork for the strength of the auditing program. She is very strong at planning and execution. She is capable of multi-tasking and managing the work well within the stipulated timelines. Athena was a key contributor to the success of the CQA program. Besides knowledge and talent she was a pleasure to work with and learn from. She would be an asset to any company's team and would raise the bar for compliance.
Donna M. Stram
She's basically a wizard. In all seriousness, Ms. Thomas-Visel is extremely competent, thorough, accurate and reliable. She is a regular consultant to my company and we highly value her expertise.
Christine Kathan
Working with Athena it became evident she is an exemplary Clinical Quality Assurance Professional. She is highly knowable and experienced in Good Clinical Practice. Proficiency in leading others to a higher level of compliance is a skill she excels at. Her leadership and guidance in Auditing, Good Clinical Practice, Good Documentation Practice and ICH Guidelines laid groundwork for the strength of the auditing program. She is very strong at planning and execution. She is capable of multi-tasking and managing the work well within the stipulated timelines. Athena was a key contributor to the success of the CQA program. Besides knowledge and talent she was a pleasure to work with and learn from. She would be an asset to any company's team and would raise the bar for compliance.
Donna M. Stram
She's basically a wizard. In all seriousness, Ms. Thomas-Visel is extremely competent, thorough, accurate and reliable. She is a regular consultant to my company and we highly value her expertise.
Christine Kathan
Working with Athena it became evident she is an exemplary Clinical Quality Assurance Professional. She is highly knowable and experienced in Good Clinical Practice. Proficiency in leading others to a higher level of compliance is a skill she excels at. Her leadership and guidance in Auditing, Good Clinical Practice, Good Documentation Practice and ICH Guidelines laid groundwork for the strength of the auditing program. She is very strong at planning and execution. She is capable of multi-tasking and managing the work well within the stipulated timelines. Athena was a key contributor to the success of the CQA program. Besides knowledge and talent she was a pleasure to work with and learn from. She would be an asset to any company's team and would raise the bar for compliance.
Donna M. Stram
She's basically a wizard. In all seriousness, Ms. Thomas-Visel is extremely competent, thorough, accurate and reliable. She is a regular consultant to my company and we highly value her expertise.
Christine Kathan
Working with Athena it became evident she is an exemplary Clinical Quality Assurance Professional. She is highly knowable and experienced in Good Clinical Practice. Proficiency in leading others to a higher level of compliance is a skill she excels at. Her leadership and guidance in Auditing, Good Clinical Practice, Good Documentation Practice and ICH Guidelines laid groundwork for the strength of the auditing program. She is very strong at planning and execution. She is capable of multi-tasking and managing the work well within the stipulated timelines. Athena was a key contributor to the success of the CQA program. Besides knowledge and talent she was a pleasure to work with and learn from. She would be an asset to any company's team and would raise the bar for compliance.
Credentials
-
Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SOCRA)Nov, 2013- Sep, 2024 -
Project Management Professional (PMP)
Project Management InstituteOct, 2013- Sep, 2024 -
Registered Quality Assurance Professional
Society of Quality AssuranceApr, 2013- Sep, 2024 -
ISO 13485/9001 Lead Auditor
BSIDec, 2007- Sep, 2024 -
Registered Dietitian
Academy of Nutrition and DieteticsJun, 2007- Sep, 2024
Experience
-
Cliq Solutions, LLC
-
Business Consulting and Services
-
1 - 100 Employee
-
Chief Quality Officer, Principal Consultant
-
Sep 2016 - Present
• Evaluate company GCP processes and systems against applicable regulations (FDA, Health Canada, EMA, ISO, ICH, PMDA, etc.), SOPs and policies, and company business needs • Build, manage, and execute global pharmaceutical and medical device clinical trial audit programs (e.g. sites, trial master files (TMF), clinical databases, safety reporting, clinical study reports, systems, and vendors) • Facilitate implementation of electronic systems for clinical operations, such as clinical trial management systems, electronic source data capture systems (eSource), and electronic patient reported outcome systems (ePRO) • Audit computer systems validation and assess Part 11 compliance • Develop trial specific plans, such as Risk Management Plans and Quality Plans • Act as a quality assurance liaison between the client and the contract research organization to ensure quality oversight • Assist in the review of clinical study and regulatory documents (i.e., protocols, ICFs, final study reports, trial master file, etc.) for compliance to department SOPs, applicable regulations, and Good Clinical Practices (FDA, EMA, ISO, ICH, PMDA, etc.) • Provide inspection readiness preparation and management • Facilitate root cause analysis and corrective and preventive action (CAPA) planning • Create and provide training to GCP, regulatory expectations, and CAPA Show less
-
-
Education
-
Syracuse University
M.Engr., Biomedical Engineering (emphasis in Intellectual Property and Technology Transfer) -
Syracuse University
M.A., Nutrition Science -
New Mexico State University
B.S., Mechanical Engineering
Community
