pfm · Remote, Brazil; Remote, Colombia; Remote, Mexico · Rio de Janeiro, Rio De Janeiro, Brazil · Bogotá, Bogotá, Colombia · Mexico, Mexico
<p style="margin: 0in; font-size: 11.0pt;"><span style="font-family: Calibri;">We’re hiring a <strong>Senior </strong></span><span style="font-weight: bold; font-family: Calibri;">Clinical Trial Manager</span><span style="font-family: Calibri;"> to help build and lead our expanding clinical operations across </span><span style="font-weight: bold; font-family: Calibri;">Latin America</span><span style="font-family: Calibri;">. This is an exciting, high</span><span style="font-family: 'Cambria Math';">‑</span><span style="font-family: Calibri;">impact opportunity,</span><span style="font-family: Calibri;"> supporting rapid growth across </span><span style="font-weight: bold; font-family: Calibri;">Mexico, Brazil, Argentina, Colombia, Chile, and Peru</span><span style="font-family: Calibri;">.</span></p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"> </p> <p style="margin: 0in; font-size: 11.0pt;"><span style="font-family: Calibri;">As the clinical lead, you’ll own the planning, execution, and oversight of clinical studies, serving as the primary client contact and ensuring delivery in compliance with protocol, SOPs, ICH</span><span style="font-family: 'Cambria Math';">‑</span><span style="font-family: Calibri;">GCP, and regulatory requirements. You’ll shape country</span><span style="font-family: 'Cambria Math';">‑</span><span style="font-family: Calibri;">level recruitment strategies, lead feasibility and site start</span><span style="font-family: 'Cambria Math';">‑</span><span style="font-family: Calibri;">up, guide monitoring and quality strategies, and mentor CRAs and partners as we scale a new regional team.</span></p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"> </p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;">This role offers significant <span style="font-weight: bold;">career growth</span>, including opportunities to build teams, define processes, influence culture, and step into broader leadership and project management responsibilities as the region grows.</p> <p style="margin: 0in; font-family: 'Segoe UI'; font-size: 10.5pt;"> </p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Essential functions of the job include but are not limited to: </span></p> <ul> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Primary clinical point of contact with the client</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Collaborate with PM on monthly invoicing and variance management of clinical budget</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Generate potential site list from key stakeholders and drive site feasibility process</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Develop and finalize the country recruitment/retention strategy </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Support in planning and conducting investigator meetings</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Review and/or approve of IP release packages</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: