Clinical Trial Manager - Future Roles (Mexico)

Clinical Trial Manager - Future Roles (Mexico)

Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID: 25107138

Clinical Trial Manager - Future Roles (Mexico)

We are a leading biopharmaceutical solutions organization dedicated to accelerating customer success by translating unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Job Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely), ensuring regulatory, ICH‑GCP, and Good Pharmacoepidemiological Practices (GPP) compliance.
• Assess site and site staff performance, recommend site‑specific actions, and develop action plans with guidance.
• Verify informed consent procedures, protect subject confidentiality, and assess factors affecting patient safety and data integrity.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP):
  • Assess site processes.
  • Conduct source document review of site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, driving resolution to closure within agreed timelines.
  • Utilize available hardware and software to support clinical project data review and capture.
  • Verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation and reviews of storage and security; verify IP dispensation and administration; address blinded or randomized IP issues.
• Review the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile with the Trial Master File (TMF).
• Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents per SOPs; support subject recruitment and retention.
• Manage site‑level activities, budgets and timelines; adapt to priorities under the lead CRA’s oversight.
• Act as primary liaison with project site personnel or collaborate with another CRA or Central Monitoring Associate (CMA).
• Prepare for and attend investigator meetings, sponsor face‑to‑face meetings, global clinical monitoring/project staff meetings, and training sessions.
• Provide guidance toward audit readiness; support audit preparation and follow‑up actions.
• For Real‑World Late Phase:
  • Support site throughout the study lifecycle from identification through close‑out.
  • Knowledge of local requirements for real‑world late‑phase study designs.
  • Chart abstraction activities and data collection.
  • Collaboration with sponsor affiliates, medical science liaisons and local country staff.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
• Proficient computer skills and willingness to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage travel of up to 75% on a regular basis.
• US ONLY: Deployment may require certain medical and personal information for facility access; compliance with all site requests is required.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion and determine equivalent qualifications. This description complies with all applicable legislation including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations when appropriate.