LAURA RODRÍGUEZ GUIJARRO

Performing Clinical trial assistance services for Global Clinical Operations, Johnson & Johnson Innovative Medicine - currently involved in Oncology trials (Multitumor area) Previously supporting Infectious Diseases & Vaccines area (Spain and Portugal)

• Knowledge of the new EU-CTR legislation and CTIS environment
• Submission to HA/IEC of communications required by local regulations under Royal Decree of clinical trials (Spain and Portugal)
• Supporting LTM/SSU preparing/collecting documents required for CTA submission, where applicable
• Maintaining and archiving ETMF (Vtmf), at trial country level
• Provides the following deliverables: tracks progress of the clinical trial, managing study data, investigational products, mailings and correspondence and other relevant tasks in support of the LTM/TM
• Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete
• Maintains trial, country level protocol information in trial management systems, including but not limited to relevant systems to ensure appropriate safety update distribution
• Ensures current versions of the required trial documents, trial related materials and supplies are provided to the investigational site(s) within required timeframes
• Performs study duties in adherence to the protocol, study processes, ICH-GCP, GCO SOPs, policies and local regulatory requirements and any other requirements stipulated on the study
• Ensure inspection readiness at all times
• Evaluates metric data to identify process improvements
• Mentoring and Job coach of Jr CTAs
• Local vendor payments

Strategic Resourcing specific for Janssen Cilag Spain – Metabolism & Infectious Disease area:

• Providing administrative support to the Clinical Project Manager and clinical study team as directed, in order to meet the objectives of the project and sponsor
• To ensure optimal management of all documents with logistical and administrative tasks related to trial startup, execution and closing of clinical trials
• Submissions to HA and ECs, trough HA Clinical trial portal
• Managing of safety information documentation, reporting to HA and ECs when applicable
• Ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements
• On-boarding, training and mentoring Jr. CTAs

• Managing and preparing documentation requirements of administrative specifications for public tenders
• In charge of maintaining up to date all documentation needed
• Administrative support to technical department in development of projects
• Invoicing and payments

• Management, preparation and control of documentation required in administrative specifications of public tenders
• Preparation and coordination of public licitations, from submission till adjudication
• Arrangement of documentation required for contract agreements, between public administration and company
• Administrative support to technical department

• Management consultancy Agency Performing Agency arrangements