Clinical Research

• Oversee the planning, execution, and successful completion of clinical trials
• Ensure adherence to timelines, budgets, and regulatory guidelines
• Coordinate clinical trial management delivery, resolve issues, and develop team capability
• Oversee the clinical portion of the budget and ensure efficient resource allocation
• Develop monitoring plans and tools to ensure effective study oversight
• Train and mentor Clinical Research Associates (CRAs)
• Drive enrollment and lead study start-up activities
• Review trip reports and implement corrective and preventative action plans when necessary
• Foster productive relationships with Sponsors, vendors, and cross-functional teams
• Provide strategic guidance to drive successful clinical trial outcomes

Senior Clinical Trial Manager

• Oversee the planning, execution, and successful completion of clinical trials.
• Ensure adherence to timelines, budgets, and regulatory guidelines.
• Coordinate clinical trial management delivery, resolve issues, and develop team capability.
• Oversee the clinical portion of the budget and ensure efficient resource allocation.
• Develop monitoring plans and tools to ensure effective study oversight.
• Train and mentor Clinical Research Associates (CRAs) to optimize performance.
• Drive enrollment and lead study start-up activities while adhering to timelines.
• Review trip reports and implement corrective and preventative action plans when necessary.
• Foster productive relationships with Sponsors, vendors, and cross-functional teams.
• Collaborate with cross-functional teams, manage site relationships, and provide strategic guidance.

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
• Ensure regulatory, ICH-GCP/GPP, and protocol compliance
• Evaluate site and site staff performance and recommend site-specific actions
• Communicate and escalate serious issues and develop action plans
• Verify informed consent processes and protect subject/patient confidentiality
• Assess subject/patient safety, clinical data integrity, protocol deviations/violations, and pharmacovigilance issues
• Conduct source document review and verify clinical data accuracy and completeness
• Resolve queries remotely and on site within agreed timelines
• Use hardware and software for clinical project data review and capture
• Verify electronic data capture compliance
• Manage investigational product inventory, reconciliation, storage, dispensing, administration, and labeling as applicable
• Review Investigator Site Files and reconcile them with the Trial Master File
• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Track observations, status, and action items to resolution
• Manage site-level activities and communications to meet project objectives, deliverables, and timelines
• Act as primary liaison with project site personnel or collaborate with CRAs/CMAs
• Ensure assigned sites and project-specific team members are trained and compliant
• Attend investigator and sponsor meetings, global project meetings, and clinical training sessions
• Support audit readiness and audit follow-up actions
• For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction/data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff

Clinical Trial Manager – Mexico

• Manage clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP
• Assume Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned
• Develop clinical tools, monitoring plans, monitoring guidelines, data quality plans, and master action plans
• Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials
• Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers and clinical teams on client meetings, bid defenses, hand-offs, timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Monitor clinical activity timelines and metrics, provide project status updates, review tracking tools and monitoring visit reports, implement recovery actions, and manage CRF collection and query resolution
• Monitor trial performance and contractual obligations; conduct Accompanied Field Visits and manage project financials as needed
• Communicate with study sites about protocols, patient participation, case report forms, and study-related issues
• Coordinate study start-up activities, regulatory submissions, ethics committee questions, and regulatory compliance documentation as needed
• Provide input into clinical activity forecasts
• Manage clinical resources, delegate responsibilities, and identify additional resource requirements
• May have limited line management responsibilities on assigned North American GPHS projects

Clinical Trial Manager

• Provide site management oversight, clinical monitoring, and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance, and data integrity
• Oversee site interactions from activation through closeout, including recruitment and investigator payments
• Identify clinical trial risks and develop risk mitigations
• Review study scope, budget, protocol content, and contractual obligations
• Monitor operational data, metrics, reports, timelines, quality, and budget risks
• Participate in and present at key meetings, including Kick Off Meetings
• Serve as an escalation point for investigator site communications and interact with principal investigators and site staff
• Coordinate handoffs with Study Start Up, Patient Recruitment, and Data Management teams
• Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans
• Ensure CTMS, dashboards, and other systems are configured and available, including user acceptance testing
• Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines
• Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks
• Review monitoring documentation and ensure timely delivery to company and sponsor specifications
• Provide clinical deliverable and risk status updates to clients, project management, and leadership
• Support inspection readiness, corrective action plans, data cut, and database lock deadlines
• Provide performance feedback to line managers
• Coordinate clinical activities across complex trials or portfolios
• Coach and mentor CTMs on clinical delivery, project risks, and action implementation

Clinical Trial Manager II

• Serve as the main point of contact for healthcare providers, sites, and patients
• Coordinate and monitor non-interventional studies, including pregnancy registries and retrospective chart reviews
• Collect, review, and manage study data through electronic case report forms (eCRFs)
• Ensure data accuracy and adherence to protocols and regulations
• Conduct remote interviews, data entry, and data review
• Maintain essential documentation and audit readiness throughout the study
• Track data trends, perform data cuts, and contribute to analysis and reporting
• Support non-interventional clinical research studies and patient registries

Patient & Healthcare Provider Support Associate – Non-Interventional Clinical Research

• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Perform department, internal, country and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget and to a high-quality standard
• Communicate project risks to project leads and line manager
• Maintain study-specific documentation, team lists, training trackers, system access management and project activity plans
• Keep the electronic Trial Master File (eTMF) up to date and document review findings
• Provide system support, including GoBalto and eTMF
• Support risk-based monitoring (RBM) activities
• Process documents for the client eTMF, perform eTMF reviews, mass mailings and communications, and provide reports to internal team members
• Schedule and organize client/internal meetings and complete meeting minutes
• Review and track local regulatory documents
• Transmit documents to the client and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports
• Assist with clarification and resolution of site-documentation findings
• Maintain vendor trackers
• Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites
• Assist with study-specific translation materials and translation quality control
• Attend kick-off meetings and take notes when required
• Act as a cross-functional liaison and potential study lead
• Support onboarding as a buddy and train new staff as needed
• Support departmental and cross-functional process-improvement initiatives

Trial Delivery Specialist – Clinical Trial Coordinator

• Monitor clinical trial sites through on-site and remote visits
• Build and maintain strong relationships with investigators and site staff
• Collaborate with cross-functional teams to meet project timelines
• Manage site-level study documentation and systems updates
• Prepare visit reports
• Implement corrective actions when needed to maintain study integrity
• Ensure sites are always audit- and inspection-ready

Clinical Research jobs in Mexico

Senior Clinical Trial Manager

Senior Clinical Trial Manager

Clinical Trial Manager – Mexico

Clinical Trial Manager

Clinical Trial Manager II

Patient & Healthcare Provider Support Associate – Non-Interventional Clinical Research

Trial Delivery Specialist – Clinical Trial Coordinator

Clinical Research Associate II – Senior