Clinical Trial Lead - HOME BASED

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="color: black; font-family: arial,helvetica,sans-serif; font-size: 10pt;">The Clinical Project Leader is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project. The CPL is responsible for coordinating and managing the clinical operations and local site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;"><span style="color: black;"> </span></span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;"><span style="color: black;">This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.</span></span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 10pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">As a Clinical Project Leader your main responsibilities will be:</span></strong></p><ul><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Ensure the fulfilment of objectives defined in the protocol (number of patients and centres, timelines, budget).</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Ensure the ICH-GCP, corporate & local SOPs, and local regulations are respected and followed by all parties.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Participate in the submission of the project to the Ethics Committees and Health Authorities.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Validate the translation and adaptation of required documentation (protocol, informed consent form...), together with the Medical Advisors.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Actively ensure the obtaining of any study related documentation required for CTA application according to local regulation and Corporate & local SOPs, together with the Support Services Manager.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Finalize financial agreements (negotiation with the investigator, hospital, university, pharmacy, contractors, etc.).</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Participate in the validation of Case report Forms (CRFs) when applicable</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Select potential investigating centres according to their qualifications, clinical experience, research background and areas of expertise, in agreement with the Medical Advisors and Lead CPL.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Organize Local Investigator's Meetings and coordinate Investigator teams attendance to International Inv. Meetings.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Supervise, coordinate and lead CRA and CPA activities.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Identify any specific problem related to the study, and propose possible solutions in agreement with Lead CPL</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Ensure good site activation. In particular ensures that the Investigators are perfectly informed of the specific features of the study and its organization.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Monitor study progress: conduct co-monitoring when necessary, evaluate Monitoring Visit Reports, measure gap between planned and actual values (visits, monitored & compiled CRFs, DRFs), alert the project team, and make the necessary decisions and actions to solve any study related matter under his/her responsibility.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Supervise recruitment and motivate investigating centres (follow-up, newsletters, information on study progress, etc.). Ensure that they have and maintain adequate equipment, materials and personnel to conduct the trial.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Conduct micro-planning follow-up in order to ensure that the committed targets (# active sites, # patients enrolled) are met in the committed administrative timelines, for the respective allocated clinical trials & Corporate Clinical Teams.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Monitor patient safety and drug tolerability by documenting adverse events, together with the GPE (Global Pharmacology and Epidemiology)</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Control the quality of data collected, technical validation of CRFs.</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Comply with the deadlines fixed by Data Management</span></li><li><span style="font-family: arial,helvetica,sans-serif; font-size: 10pt;">Handle issues specifically related to the study: critical events, patient narratives, Clinical Study Report.</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="color: black; font-family: arial,helvetica,sans-serif; font-size: 10pt;">University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution</span></li><li><span style="color: black; font-family: arial,helvetica,sans-serif; font-size: 10pt;">Fluency in English, Spanish (Portuguese is a plus but not mandatory)</span></li></ul><h2>Experience:</h2><p style="margin: 0px;"> + 1 year of experience managing Clinical Trials</p>