Site Activation Specialist For Bra Sites - English And Portuguese Advanced - Hybrid In Buenos Aires
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- Buenos Aires
- Permanente
- Tiempo completo
Job Responsibilities 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 activation.
Ensures local activities are undertaken in accordance with agreed timelines, budgets, and quality standards, and maintains an efficient start-up process on assigned studies.
May act as main contact with Regulatory Authorities and Ethics Committees under supervision and may directly interact with customers regarding regulatory requirements.
Accountable to the Project Lead, Site Activation Manager and line manager for deliverables.
Core Responsibilities Provide support to sites in Brazil.
Ensure quality of deliverables at the country level, following project requirements and applicable country rules, under oversight from the SSU Country Manager.
Work within forecasted submission/approval timelines, track milestone progress, provide rationale for delays, assist with contingency plans, and elevate issues timely.
Monitor financial aspects of the project and available hours/tasks per contract, escalating discrepancies promptly.
Review and comply with SOPs and WIs, keep training records updated, and ensure timesheet compliance.
Ensure submission of relevant documents to the Trial Master File per company SOP and sponsor requirements.
Responsible for one or more functions at the country level: Local Submissions Specialist – follow project direction, serve as point of contact during start-up, compile and review essential document packages, and assist with essential document collection.
Prepare and submit Central EC, Local EC, RA applications and other local regulatory submissions; handle ongoing submissions, amendments, and periodic notifications, including safety notifications.
Act as liaison between investigational sites and functional leads, oversee site activation end-to-end at the country/site level.
Local Site ID and Feasibility Support – collaborate with site selection lead and PM/SAM to ensure appropriate sites are selected based on study requirements.
Local Investigator Contract and Budget Negotiator – support SAM in agreeing on country template contract and budget, assist with contract negotiations, quality control, and execution.
Qualifications Previous experience in site startup or activation is highly valued.
Advanced English and Portuguese language proficiency.
Associate's degree or equivalent combination of education and training.
Good understanding of the clinical trial process across Phases II-IV and ICH GCP; ability to interact effectively with investigative site personnel.
Strong organizational skills and attention to detail; proven ability to handle multiple tasks.
Capability to set priorities under direction from multiple individuals.
Effective communication across multiple functional groups (clinical team, PM, Director).
Demonstrated independent work and team collaboration; strong problem-solving skills.
Quality-driven approach to all managed activities.
Flexibility and willingness to adapt to a rapidly changing environment.
Proficiency in Word, Excel, PowerPoint, Publisher.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, and conforms to anti-discrimination requirements under applicable laws.
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