Experience

Syneos Health
• United States
• Biotechnology Research
• 700 & Above Employee
• Clinical Trial Manager

  • Dec 2022 - Present


VaxTrials

• Panama
• Research Services
• 100 - 200 Employee

• CRA Manager

  • May 2021 - Oct 2022

  Hire/evaluate (new) team members (CRA, CTA), ensuring they are adequately qualified for their role & tasks. Onboard and train CRA & CTA’s. Evaluate CRA & CTA’s performance and quality of work as well as current vs. expected capabilities, remotely or face-to-face. Define formal, relational, and on-the-job training and development opportunities. Perform regular line-management tasks/manage staff in the day-to-day performance of their jobs. Plan and execute CRA & CTA FTE resource demand vs. supply, including strategic allocation to studies and programs. If a pplicable, accompany smooth handover process between CRA & CTA's. - In collaboration with internal stakeholders. Suggest and develop improvements to systems and processes. Show less



Labcorp Drug Development

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Clinical Research Associate

  • Jul 2015 - May 2021

  Responsible for all aspects of study site management, site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy. Prepare accurate and timely trip reports. Review progress of projects and initiate appropriate actions to achieve target objectives. Perform Serious Adverse Event reconciliation and work with sponsor, study sites and manager(s) to solve discrepancies. Participate in the development of protocols and Case Report Forms as assigned. Interact with internal work groups to evaluate needs, resources and timelines. Show less



Novartis de Colombia S.A

• Clinical Trials Medical Affairs Manager

  • Nov 2011 - May 2015

  Manager of Medical Affairs trials, responsible for the management of Phase IV clinical trials in General Medicine including development and implementation of local, regional and global clinical projects, and Investigator Initiated Studies IIT / Third Party Studies TPS, assuring all studies are originated and conducted as per ICH-GCP, applicable regulatory requirements and company procedures. Strong interactions with medical key opinion leaders and investigational / health centers. Responsible for issuing and updating of company’ Standard Operation Procedures for Medical Affairs and Clinical Trials, including personnel training and compliance with company policies. Leader of Process Improvement activities under Lean Thinking, focused to improve company competitiveness and efficacy of key processes in Medical, Quality, Pharmacovigilance and Clinical Trials. Show less

• Senior Monitor

  • Mar 2003 - Oct 2011

  Primary site contact and site manager for all operational and routine protocol issues in support of Phase II-IV clinical research studies in General Medicine. Communicate with sites on issues related to protocol conduct, enrollment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments. Perform on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, Company' global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. Perform source document verification of subject data and query resolution. Manage at least a full complement of sites with multiple protocols depending on study/site complexity. Provide input to Site Selection utilizing site evaluation and validation processes. Maintains accurate study site information in the ClinAdmin System and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study closeout. Show less



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Dec 2001 - Dec 2002

  Primary site contact and site manager for all operational and routine protocol issues in support of Phase II-IV clinical research studies in General Medicine. Communicate with sites on issues related to protocol conduct, enrollment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments. Perform on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, Company' global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. Perform source document verification of subject data and query resolution. Manage at least a full complement of sites with multiple protocols depending on study/site complexity. Provide input to Site Selection utilizing site evaluation and validation processes. Maintains accurate study site information in the ClinAdmin System and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study closeout. Show less