Site Activation Specialist II – Min 2 years of regulatory experience in Mexico
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Job Description
Site Activation Specialist responsible for quality deliverables in clinical trials and regulatory compliance in Mexico. Collaborating with cross-functional teams to manage timelines and submission processes for trial activations.
Responsibilities:
- 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.
- 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.
- Follows the project direction provided by the designated country start-up advisor (CSA) and SAM.
- May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects.
- 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.
Requirements:
- Minimum 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.
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.
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