Marta Monteiro Email and Phone Number

• Lead and coordinate project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget• Monitors and communicates project progress to the Sponsor and project team including use of tracking tools/metrics• Establishing and maintaining excellent working relationships with external and internal stakeholders, including investigators, monitors, auditors, project managers, and regulatory affairs responsible• Write and/or review abstracts and manuscripts and being accountable for managing the task until the final submission• Write and edit clinical development related documents such as clinical study protocols, informed consent forms, clinical study reports, statistical analysis plan and other clinical documents• Regulatory study submissions, tracking until approvals and communication with the Competent Authorities• Trains and mentors new or junior team members• Ensure that studies are conducted in accordance with the study protocol, SOPs, ICH-GCP and all applicable regulatory requirements

• Write and edit clinical development related documents such as clinical study protocols, informed consent forms, clinical study reports, statistical analysis plan and other clinical documents• Collect, register and archive information and documents in accordance with the applicable good clinical practice guidelines for clinical studies• Regulatory study submissions, tracking until approvals and communication with the Competent Authorities• Prepare investigator site files, trial master files (TMF) and electronic trial master files (eTMF)• Responsible for recruitment process and biometrical evaluations• Experimental data entry, data review and statistical analysis according to data management plan andstatistical analysis plan• Ensure that studies are conducted in accordance with the study protocol, SOPs, ICH-GCP and all applicable regulatory requirements