Site Activation Specialist II – Min 2 years of regulatory experience in Mexico

Role Overview

• Responsible for the quality deliverables at the country level;
• follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time;
• if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, 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 Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for the Local Submissions Specialist
• Follows the project direction provided by the designated country start-up advisor (CSA) and SAM.
• Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country;
• includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.
• Oversee site activation end to end process at country/ site level.
• Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).

Requirements

• Min 2 years of regulatory experience in Mexico
• Bachelor’s Degree.
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start-up processes.
• Ability to manage external vendors to contract effectively.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Ability to manage multiple project budgets with increased complexity and value.
• Quality-driven in all managed activities.
• Good negotiating skills.
• Good problem-solving skills.
• Demonstrated ability to work independently as well as part of a team.

Tech Stack

• Google Cloud Platform

Benefits

• We are passionate about developing our people, through career development and progression;
• supportive and engaged line management;
• technical and therapeutic area training;
• peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.