Site Activation Specialist - Futures Roles (Mexico)

Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID:25107153

Job Title

Site Activation Specialist - Futures Roles (Mexico)

Job Summary

Performs assigned activities within the country that lead to start‑up of investigative sites in all phases of clinical trials. Responsible for delivery, with oversight from the Line Manager, in areas such as investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities.

Core Responsibilities

• General – Responsible for delivering quality deliverables at the country level, following project requirements and applicable country rules, with oversight from the SSU Country Manager.
• Works within forecasted submission/approval timelines and ensures compliance, tracking milestone progress in the agreed SSU tracking system in real time; if forecasted timelines are not reached, provide clear rationale for delays, assist with contingency plans, and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with SOPs and WIs, keeps training records updated accordingly and ensures timesheet compliance.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Functions at Country Level

• Local Submissions Specialist – Follows the project direction provided by the designated country start‑up advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM during start‑up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from sites.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager.
• Acts as a liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees the site activation end‑to‑end process at the country/site level.
• Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget. Assists in producing site‑specific contracts from country template. Under supervision assists in negotiations of budget and contract with sites and via the Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

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.