Lisbon Metropolitan Area
CRA in multisponsor team. - Successfully managed high-enrolling sites (100+ patients total) in a Phase 3 trial for Acute Coronary Syndrome; - Supported a clinical trial site during a sponsor audit, ensuring preparedness and compliance with regulatory standards; - Fostered collaboration among onsite and remote monitoring teams and eTMF specialists by establishing a dedicated space for communication, issue resolution and continuous improvement. - Lead a challenging site to meet final database lock timelines. By facilitating communication between Data Management, the Sponsor and the Site, coordinated the resolution of 50+ queries on the final day, ensuring no re-queries; - Built strong relationships with major stakeholders in a leading oncology trial site, fast-tracking site selection process, and achieving first site selected in EMEA; - Proactively developed and implemented strategies to streamline data entry by 71 % and expedite query resolution by 81 %, within one month; - Adapted to shifting priorities while focusing on patient safety, critical processes and key deliverables. Promptly escalated issues with a proposed action plan. - Mentored CRA trainee Cumulative Clinical Trial experience: - 20+ trials (67% Ph3; 24% Ph2; 5% Ph 1 and 4) - Infectious Diseases (COVID-19, HIV, Community Acquired Pneumonia) - Oncology (NSCLC, HNSCC, GIST, Pancreatic Cancer, Pan-tumor phase 1 studies) - Nephrology (Dialysis and Secondary Hyperparathyroidism, Lupus Nephritis) - Neurology (Frontotemporal Dementia) - Cardiology (Acute Coronary Syndrome Pulmonary Hypertension) - Gene therapy for rare diseases Cumulative Vendor Experience: - EDC: Medidata Rave; iMedidata; Veeva CDMS; InForm - eTMF: Veeva Vault; Wingspan - CTMS: Veeva CTMS; Siebel CTMS - Central Labs: PPD Labs, Labcorp and Q2 (Couriers: DHL and Marked) - IWRS: Almac, Endpoint, Cenduit, PPD IRT and Medidata - Patient travel and reimbursement: Greenphire and Scout - Imaging and ECG: Clario - ePRO: ERT/Clario and Labcorp
- Worked in FSO and FSP environments; - Effectively managed and coordinated blinded and unblinded Phase 2 and Phase 3 monitoring and site management from selection to close-out; - Performed thorough remote and on-site visits, meticulously assessing compliance with protocols/regulations , managing documentation and ensuring audit readiness; - Anticipated and mitigated risks through critical thinking and result-oriented approach to ensures site compliance. - Participated in investigator meetings, identified potential investigators and implemented patient recruitment strategies; - Provided timely status reports and communicated effectively and develop collaborative relationships with stakeholders; - Contributed to process improvement and ensured subjects' safety, rights, well-being, and data integrity; -Supervised two patient roll-over to post-trial access programs, meeting sponsor timelines.
On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD. Together, Thermo Fisher and PPD share the pursuit of a common goal: to enable customers to make the world healthier by accelerating the development of new medicines.
- Shadowed CRA during onsite and remote monitoring visits, following a risk-based methodology; - Participated in one interventional study with 100% remote monitoring and 0% SDV; - Ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up; - Established and maintained regular communication channels with site staff, promptly addressing protocol inquiries and facilitating smooth site payment processes; - Supported site during an audit. No critical/major findings noted; - Reviewed paper and electronic Investigator files.
- Validated medical prescriptions for inpatients and outpatients with a clinical pharmacy approach; - Carried out pharmacokinetic drug monitoring of antibiotics using Bayesian models; - Compounded chemotherapy, immunotherapy, parenteral nutrition, and non-sterile (capsules, solutions and suspensions, creams and ointments, gels) medicines and performed the respective quality control; - Shadowed the hospital pharmacist responsible for managing the clinical trials.
- Managed of incoming orders, stock levels and warehouse organization ; - Validated medical prescriptions and dispensed the prescribed medicines, while ensuring proper medicine use and compliance to therapy; - Detected and notified adverse events; - Counselled over-the-counter medicines and health products; - Measured anthropometric and analytical parameters; - Compounded medicines for human and veterinary use.