CTM or Sr. CTM , FSP- Mexico
LocationRemote, Mexico
Work moderemote
Typefull-time
SeniorityDirector
Company size10,000+ people
PostedOct 8, 2026 · 4d ago
Verified live17h ago
At a glanceSummarised by Seekless from the posting.
Lead Local Study Team(s) at country level
Compliance with AZ Procedural Documents, ICH-GCP and local regulations
Perform site monitoring as needed
Responsible for study commitments within the country and timely delivery of data
Lead Local Study Team consisting of CRA(s), CSA(s)
Perform clinical and operational feasibility assessment
Coordinate site selection process
Timely submission of application/documents to EC/IRB and Regulatory Authority
Prepare country financial Study Management Agreement and maintain budget
Prepare local Master CSA and amendments
Prepare country level Master Informed Consent Form
Ensure trial essential documents collected and verified
Plan and coordinate local drug activities
Set up and maintain study in CTMS and local websites
Oversee and manage monitoring activities
Review monitoring visit reports and advise monitors
Perform co-monitoring and training visits
Identify risks and resolve study problems
Organize Local Study Team meetings
Build relationships with team, sites, and global stakeholders
Report study progress to Global Study Associate Director/Team
Contribute to patient recruitment strategy
Develop and maintain risk management plan
Communicate with National Co-ordinating Investigator
Plan and lead National Investigator meetings
Assist in forecasting study timelines, resources, recruitment, budget
Ensure systems set-up for safety, regulatory, transparency
Ensure accurate study payments
Participate in training and coaching new team members
Ensure completeness of eTMF
Plan and lead activities for audits and inspections
Provide input to process development
Provide information to Line Managers on study milestones
Update Line Managers on CRA/CSA performance
Provide feedback on research related information
Collaborate with local Medical Affairs team
Support SMM in initiatives
Ensure compliance with local policies and code of ethics
Ensure compliance with AstraZeneca’s Code of Ethics and company policies
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
About the role
To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
Nice to have
TU preference: Oncology
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