Clinical Trial Manager (LATAM)

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<p> </p> <p style="margin: 0in; font-size: 11.0pt;"><span style="font-family: Calibri;">We’re hiring a </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 based in </span><span style="font-weight: bold; font-family: Calibri;">Mexico</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: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Responsible for eTMF implementation and management </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, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Work closely with PM for project-specific resourcing issues</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Escalate pertinent CRA performance and site compliance issues when necessary</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Manage processes for investigational product (IP) including drug accountability and reconciliation </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Support business development and marketing activities as appropriate </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">May negotiate site budget and investigator contract with support from the legal department and/or site contracts group</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">May perform clinical data review of patient profiles, data listings and summary tables, including query generation</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">May have line management responsibilities</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Performs other duties as assigned by management</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Qualifications:</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;"><span style="font-weight: bold;">Minimum Required:</span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span class="T286Pc" data-sfc-cp="" data-processed="true">Professional working proficiency in English required</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"> </p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Preferred:</span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Advanced degree</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"> </p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Other Required:</span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Excellent communication and interpersonal skills to effectively interface with others in a team setting</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Excellent organizational skills, attention to detail, and a customer service demeanor</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ability to travel domestically and internationally including overnight stays</span></li> </ul> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"> </p> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><span style="font-weight: bold;">Competencies: </span></p> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Working knowledge of clinical management techniques and tools</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Direct work experience in a cross-functional environment</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics </span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Proven experience in planning, risk management and change management</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ability to lead and inspire excellence within a team</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Results oriented, accountable, motivated and flexible</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Excellent presentation, verbal and written communications skills</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">In depth proven experience in pharmaceutical and/or device research required</span></li> <li style="margin-top: 0; margin-bottom: 0; vertical-align: middle;"><span style="font-family: Calibri; font-size: 11.0pt;">Demonstrated successful independent negotiation and conflict management strategies </span></li> </ul> <h6>#LI-AG2 #LI-REMOTE</h6><div class="content-conclusion"><hr> <p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0">Privacy Policy.</a> For CA applicants, please also refer to our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0">CA Privacy Notice</a>.</p> <p>Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p> <p>If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at <a href="mailto:myHR@precisionmedicinegrp.com">myHR@precisionmedicinegrp.com</a>.</p> <p><span data-teams="true"><strong>Recruitment Fraud Warning: </strong>Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at <a id="menur2oq" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="mailto:myHR@precisionmedicinegrp.com" target="_blank">myHR@precisionmedicinegrp.com</a> so we can investigate and take appropriate action.</span></p></div>

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