Clinical Trial Manager (CTM) - Mexico

Syneos Health, Inc.; Ciudad de México; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

Syneos Health in Mexico City is seeking a Clinical Trial Manager (CTM) to oversee site management, monitoring, and central monitoring deliverables with emphasis on patient safety and data integrity. You will coordinate CTMS, EDC, eDiary and other systems; lead CRAs and central monitors; manage risks, timelines, and budgets, while collaborating across Study Start Up, Data Management and Recruitment teams.

Applicants should hold a Bachelor's or RN, have GCP/ICH knowledge, and strong communication

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Ability to lead and align teams in the achievement of project milestones.
• Capable of working in an international environment.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Moderate travel, approximately 20%.
• Good computer skills; strong communication, presentation and interpersonal skills.

Responsibilities

• Oversee site management, clinical monitoring and central monitoring deliverables.
• Manage risks to timelines, quality and budget; escalate as needed.
• Coordinate CTMS, EDC, eDiary, TMF and other systems for site activities.
• Train study team on protocol specifics, data plans and timelines.
• Ensure regulatory compliance and patient safety throughout the study.
• Support site activation, enrollment targets and milestones.

Skills

Team leadership

Budget management

Risk-based monitoring

GCP/ICH knowledge

Communication skills

Problem solving

Education

Bachelor’s degree or RN in a related field

Job description

Clinical Trial Manager (CTM) - MexicoThis website uses cookies to enhance user experience and to analyze performance and traffic on our website. We also share information about your use of our site with our social media, advertising and analytics partners. Privacy Notice# Work Here Matters Everywhere## Clinical Trial Manager (CTM) - MexicoApply: Hybrid: MEX-Mexico City-Hybrid: Full time: Posted Today: 25113164Clinical Trial Manager (CTM) - MexicoSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.Discover what our 29,000 employees, across 110 countries already know.**WORK HERE MATTERS EVERYWHERE**Why Syneos Health* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.* We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.**Job Responsibilities**JOB RESPONSIBILITIES Responsible for site management oversight, clinical monitoring and central monitoring deliverableswith a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment,investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and riskmitigations related to completion of the Risk Assessment and Categorization Tool (RACT). Reviews the study scope of work, budget and protocol content and ensures the clinical project team(CRAs/Central Monitors) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trialmanagement deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, qualityand budget) and any activities and requests which are out of contracted scope. Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. Serves as an escalation point for communications with investigator site staff and may be required tointeract on the phone or in person with principal investigators or other site staff members. This mayinclude accompanying CRA team members to sites for observation or conflict resolution. Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and DataManagement to coordinate delivery handoffs and meet expected study milestones such as siteactivation targets, enrollment targets and database lock timelines. Reviews and provides feedbackon other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to theclinical trial management activities. Responsible for development and ongoing maintenance of clinical study tools and templates,including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set upand available for use by the clinical team, including overseeing user acceptance testing (UAT) asneeded. Ensures access and audit trail reviews are conducted as required. Coordinates initial and ongoing training to the study team regarding protocol specificities, CaseReport Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs),clinical plans and guidelines, data plans and timelines for the study. Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study teammembers' conduct, and identifies risks to delivery or quality. Ensures quality of the clinical monitoring, central monitoring and site management deliverables withina project and maintain proper visibility of its progress by the use of approved systems and / ortracking tools. Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical TrialManagement System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient ReportedOutcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to overseesite and patient activities, study team conduct and to ensure the data has been updated to reflecttimely execution of all operational aspects (required visits/calls, duration, and frequency) according toplan. Understands the monitoring strategy required for the study and, where required, participates in thedevelopment of the study risk assessment plan. Is accountable for their assigned clinical teammembers' understanding, ongoing compliance and delivery according to the stated monitoringstrategy, CMP/SMP, and risk plans. Reviews the content and quality of site and central monitoring documentation (site monitoring calls,site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure theyrepresent site management activities and conduct and that they appropriately convey any risks toprotocol/GCP compliance, trial conduct, patient safety or data integrity. Document requestedrevisions and approvals in CTMS. Ensures these deliverables are provided according to companyand/or sponsor specifications, including delivery deadlines. Interacts with the client and other functional departments related to clinical monitoring, centralmonitoring and site management activities and deliverables. Provides status updates on the clinicaldeliverables and risks to clients, project management and leadership as per departmental or studyagreements. Provides solutions for obstacles in protocol execution and site management. Demonstrates understanding of other functions' roles in achieving compliance and delivery accordingto protocol, SOPs, ICH GCP and country regulations. This may include data management, study startup, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).Supports Inspection Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specificprocess and training compliance, CMP compliance, and identifies emerging risks. May develop andsupport execution of corrective action plans at site and study level. Supports and completes acti vitiesto achieve data cut and lock deadlines. Provides feedback to line managers on staff performance including strengths as well as areas fordevelopment. QUALIFICATION REQUIREMENTS Bachelor’s degree or RN in a related field or equivalent combination of education, training andexperience Ability to lead and align teams in the achievement of project milestones Capable of working in an international environment Previous clinical trial experience in site management Preferred experience with risk-based monitoring and clinical or central monitoring Familiar with financial principles and budget management practices Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills Good communication, presentation and interpersonal skills among project team and with sites Basic conflict resolution skills Ability to apply problem solving techniques to resolve complex issues and apply a risk managementapproach to identifying and mitigating potential threats to the successful conduct of a clinical researchproject. Demonstrates critical thinking to determine the cause and appropriate solution in the identification ofissues Moderate travel may be required, approximately 20%# We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.**Get to know Syneos Health**Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.http://www.syneoshealth.com**Additional Information**Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.