Margarida Vale Email & Phone Number

Lisbon, Pt

Braga, Portugal

Therapeutic Areas: Neurology, Breast Cancer (phase I, II & III studies)Tasks and Responsibilities:- Trainer at IQVIA's CRA School (for EMEA)- Perform Accompanied Site Visits to assess and coach CRAs- Mentoring of junior CRAs- Local Subject Matter of Expert for Risk Based Quality Management methodology- Conduct of on-site visits and remote monitoring activities in accordance with the approved monitoring plan;- Assess the investigational product through physical… Show more Therapeutic Areas: Neurology, Breast Cancer (phase I, II & III studies)Tasks and Responsibilities:- Trainer at IQVIA's CRA School (for EMEA)- Perform Accompanied Site Visits to assess and coach CRAs- Mentoring of junior CRAs- Local Subject Matter of Expert for Risk Based Quality Management methodology- Conduct of on-site visits and remote monitoring activities in accordance with the approved monitoring plan;- Assess the investigational product through physical inventory and records review;- Support to issues and query resolution;- Document monitoring activities through reports and follow-up letters;- Communicate with site staff to assure compliance with protocol and applicable regulations and provide support;- Interact with the study systems (eCRF, CTMS, eTMF, etc.);- Manage the essential documents, as required by local regulations throughout the trial. Show less

Lisbon, Portugal

Therapeutic Areas: Neurology, Breast Cancer (phase II & III studies)Tasks and Responsibilities:- Mentoring of junior CRAs;- Local Subject Matter of Expert for Safety Document Distribution through TransCelerate's Shared Investigator Platform.- Conduct of on-site visits and remote monitoring activities in accordance with the approved monitoring plan;- Assess the investigational product through physical inventory and records review;- Support to issues and query… Show more Therapeutic Areas: Neurology, Breast Cancer (phase II & III studies)Tasks and Responsibilities:- Mentoring of junior CRAs;- Local Subject Matter of Expert for Safety Document Distribution through TransCelerate's Shared Investigator Platform.- Conduct of on-site visits and remote monitoring activities in accordance with the approved monitoring plan;- Assess the investigational product through physical inventory and records review;- Support to issues and query resolution;- Document monitoring activities through reports and follow-up letters;- Communicate with site staff to assure compliance with protocol and applicable regulations and provide support;- Interact with the study systems (eCRF, CTMS, eTMF, etc.);- Manage the essential documents, as required by local regulations throughout the trial. Show less

Lisbon, Portugal

Therapeutic Areas: Ophthalmology, Neurology, Oncology (phase III-IV studies)Tasks and Responsibilities:- Conduct of on-site visits and remote monitoring activities in accordance with the approved monitoring plan;- Assess the investigational product through physical inventory and records review;- Support to issues and query resolution;- Document monitoring activities through reports and follow-up letters;- Communicate with site staff to assure compliance with protocol… Show more Therapeutic Areas: Ophthalmology, Neurology, Oncology (phase III-IV studies)Tasks and Responsibilities:- Conduct of on-site visits and remote monitoring activities in accordance with the approved monitoring plan;- Assess the investigational product through physical inventory and records review;- Support to issues and query resolution;- Document monitoring activities through reports and follow-up letters;- Communicate with site staff to assure compliance with protocol and applicable regulations and provide support;- Interact with the study systems (eCRF, CTMS, eTMF, etc.);- Manage the essential documents, as required by local regulations throughout the trial. Show less

Lisbon, Portugal

Teaching Clinical Trial Monitoring to students from Master in Clinical Research Management.Developed in partnership with NOVA University Lisbon (NOVA Medical School, IMS and National School of Public Health) and University of Aveiro, the Master's in Clinical Research Management aims to train specialized professionals in the field of clinical research and clinical trial management.

Lisbon, Portugal

Therapeutic Areas: Oncology, Infectious Diseases (phase III studies)Tasks and Responsibilities:- Conduct of on-site and remote monitoring visits in accordance with the approved monitoring plan;- Source Data Review and Verification;- Assess the investigational product through physical inventory and records review;- Support to issues and query resolution; - Document visits through report and letter elaboration; - Communicate with site staff to assure compliance… Show more Therapeutic Areas: Oncology, Infectious Diseases (phase III studies)Tasks and Responsibilities:- Conduct of on-site and remote monitoring visits in accordance with the approved monitoring plan;- Source Data Review and Verification;- Assess the investigational product through physical inventory and records review;- Support to issues and query resolution; - Document visits through report and letter elaboration; - Communicate with site staff to assure compliance with protocol and applicable regulations and provide support; - Interact with the study systems (eCRF, CTMS, Preclarus®, etc.);- Manage investigator payments;- Manage the essential documents, as required by local regulations throughout the trial. Show less

Lisbon Area, Portugal

Therapeutic Areas: Haematology, Neurology (phase III and non-interventional studies)Tasks and Responsibilities:- Investigator's Meeting attendance;- Autonomous conduct of On-site Monitoring Visits and Remote Monitoring procedures;- Source Data Verification, CRFs review for completeness and support to query resolution; - Visits report and updates elaboration; - Site staff communication and support; - Tracking timelines and recruitment status; - Contact with… Show more Therapeutic Areas: Haematology, Neurology (phase III and non-interventional studies)Tasks and Responsibilities:- Investigator's Meeting attendance;- Autonomous conduct of On-site Monitoring Visits and Remote Monitoring procedures;- Source Data Verification, CRFs review for completeness and support to query resolution; - Visits report and updates elaboration; - Site staff communication and support; - Tracking timelines and recruitment status; - Contact with sponsors; - Competent Authorities/Ethics Committee submissions and notifications (local and national level);- Elaboration of financial agreements for selected centers; - Medical Writing. Show less

Lisbon Area, Portugal

Tasks and Responsibilities:- Competent Authorities/Ethics Committee submissions and notifications (local and national level);- Attendance at Site Monitoring Visits with senior CRAs followed by support in report elaboration;- Remote Close-out procedures; - Source Data Verification and CRFs review for completeness; - Visits report and updates elaboration; - Site staff communication and support; - Preparation of Investigator Site File; - Trial Master File and Sites… Show more Tasks and Responsibilities:- Competent Authorities/Ethics Committee submissions and notifications (local and national level);- Attendance at Site Monitoring Visits with senior CRAs followed by support in report elaboration;- Remote Close-out procedures; - Source Data Verification and CRFs review for completeness; - Visits report and updates elaboration; - Site staff communication and support; - Preparation of Investigator Site File; - Trial Master File and Sites Master File review for completeness. Show less

Master'S Degree, Clinical Research Management

Subjects covered: - Ethics in Clinical Research - Management Strategies in Clinical Research - Epidemiology and Methods - Statistics.

Bachelor'S Degree, Biomedical Sciences

Activities and Societies: Volunteer at BEST Aveiro; Mentor of new students at University of Aveiro; Buddie at Erasmus Student Network.