Experience

TMC Pharma Services Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead Clinical Research Associate (freelance, home-based)

  • Apr 2023 - Present



TMC Pharma Services Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Apr 2022 - Feb 2023

  • Oversee the CRA team to ensure they adhere to the study, SOP and regulatory requirements during all study phases.• Host regular CRA meetings for study-specific training and study status review.• Create and maintain the Study Monitoring Plan.• Develop study-related monitoring tools.• Review site visit reports.• Oversee study monitoring metrics (e.g. site visit frequency, submission of site visit reports, data entry timeframe, SDV, issue resolution, query resolution, etc.).• Follow-up with CRAs on reported protocol deviations to ensure appropriate actions are taken to address the root cause.• Liaise with other company departments and vendors (e.g. pharmacovigilance, data management, central lab, IRT, regulatory affairs, etc.) as needed.• Actively participate in study data cleaning throughout the study and ensure CRFs are signed off by investigators in time for database lock.• Support study management in ensuring EC and regulatory authority submissions/approvals are up-to-date.• Oversee the site-level TMF status to ensure it is current and complete. Show less

• • Feb 2019 - Mar 2022

  • Responsible for the management of assigned sites from start-up onwards.• Ensure data entry and query resolution by sites adhere to the required timelines.• Follow up on protocol deviations to ensure proper actions are taken by sites to prevent recurrence.• Follow up on site issues for timely resolution. • Liaise with the regulatory affairs vendor to ensure EC submissions for the country were completed as required.• Maintain the site-level TMF current and complete for the managed sites. Show less



Allergan (through Chiltern International Resourcing Solutions)

• Madrid, Spain

• Regional Site Manager (field-based)

  • Mar 2018 - Oct 2018

  • Ensure EC and regulatory approvals were in place prior to implementation of study documents or processes. • Follow-up on site staff training requirements. • Conduct on-site and remote (telephone) visits (initiation through to close-out) as per the study risk-based monitoring visit schedule. • Ensure site issues were resolved in a timely manner. • Achieve timely data cleaning and CRF sign-off for interim database locks. • Ensure EC and regulatory approvals were in place prior to implementation of study documents or processes. • Follow-up on site staff training requirements. • Conduct on-site and remote (telephone) visits (initiation through to close-out) as per the study risk-based monitoring visit schedule. • Ensure site issues were resolved in a timely manner. • Achieve timely data cleaning and CRF sign-off for interim database locks.



AnGes Inc. (freelance, through ExecuPharm)

• Madrid Area, Spain

• Senior CRA on a CRO oversight role (field-based)

  • Apr 2015 - Feb 2017

  • Lead the site selection process for assigned countries. • Conduct site co-visits with CRAs for quality oversight. • Review site visit reports. • Follow up on metrics (e.g. site visit frequency, issue resolution, query resolution, data entry timeframe, submission of site visit reports, shipment of bio-distribution samples, etc.). • Participate in the development of study documents and materials for CRA study-specific training sessions. • Take part in regular teleconferences with the CRO study management team. • Lead the data cleaning process towards database lock. • Reconcile the global set of bio-distribution samples. • Participate in the development of company Standard Operating Procedures. Show less



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Apr 2014 - Dec 2014

  • Provide study-specific training to CRAs to support the collection of high-quality clinical trial data.• Ensure proper training of new CRAs in the team and ensure proper site transition as required.• Follow up on study monitoring metrics (e.g. site visit frequency, issue resolution, query resolution, etc.).• Support study management in ensuring EC and regulatory authority submissions/approvals were up-to-date.• Create and maintain the Study Monitoring Plan.• Develop study-related monitoring tools.• Complete site visits across the EMEA region for quality oversight, including audit preparation.• Liaise with other company departments (e.g. training and safety departments) as well as vendors.• Collaborate with colleagues in similar roles to maintain consistency and quality across the company. Show less

• • Jan 2012 - Mar 2014

  • Mentored a team of 6 CRAs in Spain and Portugal.• Collaborated with inspection-readiness site visits across the EMEA region for a high-priority company project.• Conducted co-monitoring visits to support CRAs over high-workload periods.• Conducted Quality Assessment Visits in Spain, Portugal and Italy to evaluate CRA performance and identify CRA training needs.• Performed visit report reviews as part of the company´s quality oversight initiative.• Followed up with CRAs to ensure site issues were resolved in a timely manner.• Provided general monitoring training and guidance on company-specific processes to CRAs.• Participated in initiatives to help to improve company processes.• Main Allergan contact for matters related to clinical trials in Spain and Portugal.• Managed clinical trial sites (phases II and III). Show less



Chiltern

• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Clinical Research Associate (field-based)

  • Sep 2009 - Dec 2011

  • In addition to responsibilities listed for previous jobs: Mentor new CRAs in Spain and Portugal (May2011-Dec2011). • In addition to responsibilities listed for previous jobs: Mentor new CRAs in Spain and Portugal (May2011-Dec2011).



i3 Research

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Clinical Research Associate (field-based)

  • Mar 2007 - Sep 2008

  • Conducted site visits (selection through to close-out; GP and hospital sites on phase I-III studies) according to ICH GCP, the European Directive for Clinical Trials and the FDA CFR, as well as local regulations and applicable SOPs. • Created study-specific documents. • Achieved timely data submission for study with data locks at 6-monthly intervals. • Participated in feasibility studies across different therapeutic areas. • Assisted project management teams with review of monitoring reports. • Conducted accompanied site visits with and mentored junior CRAs. • Provided timely follow-up for audit and quality assurance activities. Show less



IQVIA

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

• Clinical Research Associate II (field-based)

  • Aug 2006 - Feb 2007

  • Conducted site visits, including pre-study, initiation and interim monitoring according to applicable SOPs, ICH/GCP guidelines and regulatory requirements. • Assessed the suitability of facilities at study centres for participation in clinical trials. • Assisted with ethics & R&D submissions. • Liaised with R&D Departments in relation to study contracts and budget. • Set up study sites and trained site staff to trial-specific and industry standards. • Ensured that data queries were resolved and Serious Adverse Events were reported within the required timelines. • Maintained clinical trial databases. Show less



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Research Associate II (previously CRA I, Jul. 2002-Jul. 2004; CTA, Jan. 2002-Jul. 2002)

  • Jan 2002 - Oct 2005

  • In addition to the standard CRA tasks, as Lead-CRA for a phase III study: - Ensured CRAs work in compliance with applicable SOPs, ICH/GCP and local regulations. - Ensured ethics committees and regulatory authority submissions / approvals were up-to-date. - Reviewed site visit reports. - Collated data for status reports to the sponsor. - Acted as intermediary between CRAs and project manager, data management and drug safety. • In addition to the standard CRA tasks, as Lead-CRA for a phase III study: - Ensured CRAs work in compliance with applicable SOPs, ICH/GCP and local regulations. - Ensured ethics committees and regulatory authority submissions / approvals were up-to-date. - Reviewed site visit reports. - Collated data for status reports to the sponsor. - Acted as intermediary between CRAs and project manager, data management and drug safety.



The City of Edinburgh Council

• Edinburgh, United Kingdom

• Administrative Assistant (Pensions Department)

  • Dec 2000 - Jan 2002

  • Handled customer enquiries. • Processed calculations of pension contributions. • Handled customer enquiries. • Processed calculations of pension contributions.



IQVIA

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

• Clinical Research Associate

  • Nov 1998 - May 2000

  • Selected, set up and monitored sites for phase III studies. • Assisted sites with local EC and R&D submissions. • Wrote and gave presentation at investigator meeting. • Selected, set up and monitored sites for phase III studies. • Assisted sites with local EC and R&D submissions. • Wrote and gave presentation at investigator meeting.



Isotec y Asociados S.A.

• Buenos Aires, Argentina

• Administrative Assistant (part-time)

  • Feb 1998 - Nov 1998



Laboratorio Dras. Benencia - Christot

• Buenos Aires, Argentina

• Laboratory Technician (part-time)

  • Oct 1997 - Nov 1998



Centro de Investigaciones Endocrinológicas, Hospital de Niños Ricardo Gutiérrez

• Buenos Aires, Argentina

• Research Fellow

  • Feb 1996 - Feb 1998



Cell Biology Institute, Medical School, University of Buenos Aires

• Buenos Aires, Argentina

• Research Laboratory Assistant

  • Oct 1994 - Nov 1995