Rosetta Dujat des Allimes Ruiz
ROZAS DE MADRID (LAS),España
Summary
Experienced professional in the pharmaceutical industry with a strong background in clinical trial management, research, and development. Knowledge and understanding of clinical research processes, regulations and methodology .Dynamic and responsible professional with strong organisational skills and a proven ability to adapt to changing needs. Demonstrates expertise in effective communication, time management, and problem-solving, complemented by a commitment to initiative and dedication. .Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations. Excels in collaborative environments, fostering teamwork while maintaining a focus on achieving objectives efficiently. Eager to contribute to roles that value adaptability, effort and commitment, continuous learning, and a results-oriented approach.
Overview
17
17
years of professional experience
2016
2016
years of post-secondary education
Work history
Senior Clinical Site Monitor,
Bristol-Myers Squibb Company
Regional Clinical Operations Iberia, Spain
05.2018 - Current
- Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
- Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
- Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies). Site experts.
- Recommends sites during the site feasibility and/or site selection process
- Conducts pre-study visit as appropriate
- Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation. Given the extensive knowledge of the responsible site, we work very closely with them, so that in most cases the sites are ready to be activated after the Site Initiation Visit (SIV).
- Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable. Visits are conducted according to the Site Monitoring Plan (SMP), but always meeting the specific needs of the study and the site. At least 2-3 visits per week if necessary.
- Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
- While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
- Serve as a point of contact for Sites
- Provides trainings to sites
- Performs site closure activities when all required protocol visits and follow-up are completed
- Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities
- Oversees activities of site personnel over whom there is no direct authority.
- Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.
- Anticipates, identifies and proactively supportssite in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
- Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
- May support Ethics Committee submission, ICF review, collection of documents to/from site
- May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel
- May support equipment calibration and tracking
- May support preparation of Study Initiation Visit materials
- May support coordination and ensure database lock timelines are met as required locally
Senior Initiation Clinical Site Manager,
AREXEL International Madrid
Madrid , Spain
01.2018 - 05.2018
- Clinical Site’s main point of contact for assigned sites, accountable for quality and delivery of sites during the pre-SIV / start-up phase. Manages country specific feasibility, site pre-qualification and qualification activities
- Build relationships with investigators and site staff
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include: o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports in accordance with monitoring plans.
- Configure, distribute, collect, review, and approve high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as required, country/site specific Informed Consent Forms (ICF), translations (in accordance with country/regulatory/client requirements), and any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s) in accordance with country/regulatory/client requirements, following up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy. Assist with forecast, development, and management of plans and strategies for: o IRB/IEC and MoH / RA submission/approval,
- Site activation,
- Patient recruitment & retention
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner, as indicated per project requirements.
- Promptly identify, use judgement and knowledge to address and resolve or escalate (if applicable, to Functional Lead), any site question and/or issue, including but not limited to: study non-compliance, potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity etc. Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Supports protocol amendments throughout the life of the study as required.
- Maintains a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training. Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.
Senior Clinical Monitoring Associate
PAREXEL International Madrid
Madrid, Spaon
09.2016 - 01.2018
- Support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. Act as PAREXEL’s remote contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
- Prepare and collect site documents, such as essential regulatory documents (SRP)
- Compile SRP for review and approval
- Submit and follow-up with site on CSA (including budget), Anti-Bribery Law (ABL) Survey (if not available), and site specific ICF. Collaborate and involve Clinical Trial Specialists (CTS) on CSA (including budget) and site specific ICF negotiations as required
- Collect site specific documents for IRB, EC, and RA as required
- Provide prepared EC package to PI for submission and follow up to secure approval where required
- Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training
- Conduct general site contacts in accordance with the study specific Monitoring Plan.
- Generate contact reports in accordance with departmental timelines and/or sponsor timelines whichever is shorter
- Prepare sites and CRAs for on-site visits
- Conduct remote visits (qualification, initiation, monitoring, and termination)
- Re-train site staff on study specific tasks/procedures remotely as required
- Ensure timely resolution and closure of all site issues
Senior Site Identification Specialist
INC Research
Madrid , Spain
11.2015 - 09.2016
- Continually builds the investigator database, establishes and maintains relationships with key investigators, collects information supporting the definition of the ideal site for a study, performs the identification of suitable sites for a study, and coordinates global efforts for site identification.
- Acts as primary contact with investigational sites to collect data for feasibility, site ID, and building the investigator database. Tracks and QCs data using TrialMD and other used systems.
- Builds local relationships with key research sites and Key Opinion Leaders.
- Acts as primary contact with the Global Feasibility team to provide country specific data for proposals (site contact, site recommendations) generated through collecting and interpreting feasibility data.
- Acts as primary contact for the Project Leader in the site ID process for awarded or ongoing trials. Participates in the site ID by preparing a site ID plan, reviews performance metrics, and recommends the most appropriate sites for a study.
- Interacts with internal and external personnel to coordinate the collection of feasibility and site ID data and supports rapid start-up of sites as needed.
- Contributes to the development and maintenance of TrialMD to build a comprehensive list of investigational sites, including obtaining consents across all therapeutic areas per country.
- Maintains feasibility database TrialMD for storage and retrieval of metrics based on site data.
- Contributes to the country plan for the study (number of sites proposed, type of sites, recruitment rates, and key challenges), and validates feasibility/site ID assessment during the study.
- Runs operational and technical aspects of large global projects.
- Assists with other Company systems activities related to the Feasibility and Site Identification
Clinical Research Network- SCReN,
Foundation for Biomedical Investigation UICEC,
Hospital Clínico San Carlos, Madrid , Spain
03.2015 - 11.2015
- Working as Project Manager in one study
- Conduct general site contacts ( review recruitment plan, follow-up on data entry, query status and SAEs, follow-up on site related questions, assess drug/study supply status
- Collect regulatory documentation
- Perform all clinical monitoring tasks for designed projects
- Prepare sites
- Investigator meeting
- Project manager tasks
Senior Clinical Research Associate, PENTA-INSERM S
PENTA-INSERM S Foundation
University Hospital La Paz, IdiPAZ, Madrid, Spain
02.2012 - 12.2014
- Monitor in charge of all the Study in Spain.
- Performed required pre-study activities
- Ensured appropriate Ethical Committee and Regulatory Agency submission and approvals, having a working knowledge of local regulatory requirements in Spain.
- Organized Investigator Meeting and assistance
- Ensure that all appropriate and required Study Documentation is obtained and filed in properly.
- Conducted Source Data Verification & performed data review in timely manner.
- Queries & safety queries.
- Carry out & document pre-study, initial, monitoring and final study visits, including final disposal of study supplies
- Drug Accountability Procedures. Reception, Dispensation, Returned, Destruction.
- SAEs reporting/ Annual Reports, News Letters.
- Meet deadlines and Interim Analysis
- Maintained meticulous documentation for easy reference and audit readiness.
- Facilitated on-site monitoring and audits, maintaining high standard of research conduct.
- Promoted adherence to Good Clinical Practice standards throughout all conducted studies.
Senior Clinical Research Associate, Freelance
GlaxoSmithKline. S.A., M
Madrid , Spain
05.2011 - 05.2013
- Monitor in charge of all Studies developed in Madrid´s Hospital.
- Participated in investigator/site selection/Feasibilities
- Performed required pre-study activities
- Ensured appropriate Ethical Committee and Regulatory Agency submission and approvals, having a working knowledge of local regulatory requirements in Spain.
- Investigator Meeting and assistance
- Ensure that all appropriate and required Study Documentation is obtained and filed in properly.
- Conducted Source Data Verification & performed data review in timely manner. Close the data base. Queries & safety queries.
- Carry out & document pre-study, initial, monitoring and close out study visits, including final disposal of study supplies
- Drug Accountability Procedures. Reception, Dispensation, Returned, Destruction.
- SAEs reporting/ Annual Reports, News Letters.
- Meet deadlines and Interim Analysis
Clinical Research Associate I
GlaxoSmithKline .S.A
Madrid , Spain
07.2008 - 05.2011
- Participated in all Monitoring activities and visits.
- Ensured appropriate Ethical Committee Communications Individuals printing or viewing a BMS controlled document from a source other than the Electronic Document Management System are responsible for ensuring that they are printing or viewing the current version.
- Ensure that all appropriate and required Study Documentation is obtained and filed in properly.
- Conducted Source Data Verification & performed data review in timely manner.
- Queries & safety queries.
- Carry out monitoring and final study visits, including final disposal of study supplies
- Drug Accountability for all treatment during the study and destruction.
- SAEs reporting.
Education
Master of Science - Trainee Clinical Research Associate,
GlaxoSmithKline S.A.
Spain 01.2008 - 07.2008
Trainee - Trainee
Pharmamar S.A.
Spain 07.2007 - 12.2007
CITIUS Leadership And Management - Post-graduate
University Autonoma, Madrid
Spain Bachelor of Science - Biological Sciences
Complutense University of Madrid
Spain 04.2001 - 07.2007
Skills
- Effective communication, Time management, Problem-solving
- Responsible, dynamic, and eager to learn
- Initiative, commitment, and dedication
- Ability to work in team and adapt to changes and needs, with excellent organizational skills
Languages
Spanish
Native
English
Advanced
Italian
Intermediate
Timeline
Senior Clinical Site Monitor,
Bristol-Myers Squibb Company
05.2018 - Current
Senior Initiation Clinical Site Manager,
AREXEL International Madrid
01.2018 - 05.2018
Senior Clinical Monitoring Associate
PAREXEL International Madrid
09.2016 - 01.2018
Senior Site Identification Specialist
INC Research
11.2015 - 09.2016
Clinical Research Network- SCReN,
Foundation for Biomedical Investigation UICEC,
03.2015 - 11.2015
Senior Clinical Research Associate, PENTA-INSERM S
PENTA-INSERM S Foundation
02.2012 - 12.2014
Senior Clinical Research Associate, Freelance
GlaxoSmithKline. S.A., M
05.2011 - 05.2013
Clinical Research Associate I
GlaxoSmithKline .S.A
07.2008 - 05.2011
Master of Science - Trainee Clinical Research Associate,
GlaxoSmithKline S.A.
01.2008 - 07.2008
Trainee - Trainee
Pharmamar S.A.
07.2007 - 12.2007
Bachelor of Science - Biological Sciences
Complutense University of Madrid
04.2001 - 07.2007
CITIUS Leadership And Management - Post-graduate
University Autonoma, Madrid
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