Site Activation Specialist I

Syneos Health

0-2 years

Not Disclosed

Brazil

10 Oct. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Site Activation Specialist I – Client Assignment in Brazil

Updated: Yesterday
Location: BRA-Client
Job ID: 25102216

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We translate clinical, medical affairs, and commercial insights into actionable outcomes to address modern market challenges.

Our Clinical Development model centers on the patient and customer while streamlining processes to make Syneos Health both efficient and employee-friendly.

Join a team of problem solvers collaborating to deliver therapies faster and improve patient outcomes.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Inclusive Total Self culture encouraging authenticity
Diversity of thought and experience to foster belonging

Job Responsibilities

General Responsibilities

Deliver high-quality outputs at the country level in compliance with project requirements and country-specific rules.
Monitor submission/approval timelines and ensure milestones are tracked in real-time using the SSU tracking system.
Provide rationales for delays, assist with contingency plans, and escalate issues when needed.
Track project financials and ensure timesheet compliance.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per SOPs and Sponsor requirements.

Functional Areas

Local Submissions Specialist

Support country start-up advisor (CSA) and Site Activation Manager (SAM) in start-up activities.
Compile and review essential documents for site activation; collect essential documents from sites.
Prepare and submit applications to Central and Local Ethics Committees (EC), Regulatory Authorities (RA), hospitals, and other local entities.
Handle ongoing submissions, amendments, periodic notifications, and safety notifications under supervision.
Act as liaison between investigative sites and functional leads, overseeing site activation end-to-end at the country/site level.

Local Site ID and Feasibility Support

Assist site selection lead, PM, and SAM to identify appropriate sites for individual studies based on clinical trial requirements.

Local Investigator Contract and Budget Negotiator

Support SAM in agreeing on country template contracts and budgets.
Produce site-specific contracts from country templates.
Assist in budget and contract negotiations with sites via Site Contracts Service Centre and SAM until execution.
Perform quality control, execute CTAs, and archive documents with metadata.

Qualifications

Relevant degree in life sciences, business administration, public health, or related field (or equivalent combination of education and experience).
Knowledge of clinical trial start-up processes and regulatory requirements.
Ability to comply with SOPs, WIs, and maintain training records.
Strong organizational, communication, and interpersonal skills.
Ability to monitor financials and timelines effectively.
Customer-focused, adaptable, and able to manage multiple priorities.

Get to Know Syneos Health

Supported 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years.
Involved in 200+ studies across 73,000 sites and 675,000+ trial patients.
Encourages initiative and challenges the status quo in a competitive, fast-paced environment.

Learn more: Syneos Health

Additional Information

Duties may change at the company’s discretion.
Equivalent experience or skills may be considered.
This description does not constitute an employment contract.
Complies with local and international employment legislation.
Reasonable accommodations provided per the Americans with Disabilities Act.

Summary

Performs country-level activities that enable start-up of investigative sites across all clinical trial phases. Responsible for investigator contracts, ethics and regulatory submissions, collection and review of essential documents, and site activation activities. Ensures timelines, budgets, and quality standards are met. May act as the main contact with regulatory authorities and central/regional ethics committees under supervision. Accountable to the Project Lead/Site Activation Manager for deliverables.

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Site Activation Specialist I

Job Description

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