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

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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.