Local Clinical Project Manager

Clinical Project Manager – Sponsor Dedicated.

Clinical Project Managers provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL).

Tasks & Responsibilities:

• Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.

• Ensure availability of required reports to support real time tracking of trial status according to trial plan.

• Manage timely and accurate documentation and communication of trial progress.

• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.

• Act as primary contact for Country and Regional staff.

• Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.

• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.

• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

Essentials Requirements:

• Bachelor’s degree (BA/BS) in a health‑ or science‑related field.

• Fluency in the local country language (spoken and written) and English is required.

• Approximately 2 years of experience in clinical trial management within the pharmaceutical industry or a CRO, supporting global or regional studies.

• Strong clinical research operations expertise, with a proven track record of managing multiple trial phases from start‑up through database lock and study close‑out.

• Ability to provide concrete, real‑life examples and clearly articulate challenging situations successfully managed throughout one’s career.

• Demonstrated strong problem‑solving skills, effective leadership capabilities, and a proactive, forward‑looking approach to risk identification and mitigation.

• Solid working knowledge of ICH‑GCP, company standard operating procedures, applicable local laws and regulations, assigned protocols, and protocol‑specific procedures.

• Strong IT literacy, including proficiency with relevant software applications and company systems.

• Willingness to travel occasionally, including overnight stays, in accordance with business needs.

• Preferably based in Mexico City, Mexico.