Site Activation Specialist assigned to client Mexico, Chile, Colombia, Brazil, Argentina

Overview

Site Activation Specialist assigned to client Mexico, Chile, Colombia, Brazil, Argentina

Responsibilities

• 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 (or designee) 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 site.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities 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 as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager.
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end to end process at 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.
• May be asked to perform: 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 assist in negotiations of budget and contract with site and via 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.

Qualifications

• Associate's Degree or equivalent combination of education and training
• Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
• Ability to take direction from multiple individuals and set priorities accordingly.
• Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
• Demonstrated ability to work independently, as well as part of a team. Utilize problem-solving techniques effectively.
• Quality-driven in all managed activities.
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.

Additional Information

We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at

Summary

• General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with 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 SOPs and WIs in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Information Technology

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