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Site Activation Specialist Ii

0-2 years
Not Disclosed
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 II – Client Assignment in Brazil

Updated: Yesterday
Location: BRA-Client
Job ID: 25102213


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate 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 simplifying processes to make Syneos Health 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 fostering authenticity

  • Diverse perspectives creating a sense of belonging


Job Responsibilities

General Responsibilities

  • Deliver quality outputs at the country level with moderate oversight from the SSU Country Manager.

  • Track submission/approval timelines and ensure compliance using the SSU tracking system; escalate issues and provide contingency plans as needed.

  • Monitor project financials, including hours/tasks per contract; escalate discrepancies promptly.

  • Review and comply with SOPs and Work Instructions (WIs); maintain training records and ensure timesheet compliance.

  • Support continuous quality improvement across Site Start-Up (SSU) components, including submissions, document collection, and communications with authorities.

  • Ensure all relevant documents are submitted to the Trial Master File (TMF) per SOP/Sponsor requirements.

Functional Areas

Local Submissions Specialist

  • Follow guidance from Country Start-Up Advisor (CSA) and Site Activation Manager (SAM).

  • Compile/review essential document packages for site activation; collect essential documents from sites.

  • Prepare and submit Central EC Applications, Local EC Applications, RA Applications, and other local regulatory submissions.

  • Handle ongoing submissions, amendments, periodic notifications, and safety notifications under moderate oversight.

  • Act as liaison between investigative sites and functional leads; oversee end-to-end site activation at the country/site level.

Country Start-Up Advisor

  • Act as Subject Matter Advisor for in-country Site Start-Up performance.

  • Maintain local regulatory intelligence on EC and CA submissions, notifications, and license applications.

  • Provide guidance on local legislation, data protection statements, and internal SOP/WI updates.

  • Support internal training material creation and issue resolution for EC or CA matters.

Local Site ID and Feasibility Support

  • Assist site selection lead and PM/SAM to identify appropriate sites per clinical trial requirements.

Local Investigator Contract and Budget Negotiator

  • Support SAM in agreeing on country template contracts and budgets.

  • Produce site-specific contracts and support submissions for proposed contracts and budgets.

  • Assist in budget/contract negotiations via Site Contracts Service Centre and SAM with Sponsor until execution.

  • Perform quality control, arrange execution of CTAs, and archive documents with metadata.


Qualifications

  • Bachelor’s degree or equivalent in relevant field.

  • Strong understanding of clinical trial processes across Phases II–IV and ICH GCP.

  • Ability to interpret clinical protocols and study specifications.

  • Detailed knowledge of clinical trial start-up processes.

  • Vendor management skills and organizational ability to handle multiple tasks.

  • Strong written/verbal communication and interpersonal skills.

  • Experience managing multiple project budgets with increased complexity.

  • Quality-driven, with problem-solving and negotiation skills.

  • Ability to work independently and collaboratively.


Get to Know Syneos Health

  • Supported 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years.

  • Contributed to 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, skills, or education may be considered.

  • This description does not constitute an employment contract.

  • Complies with local and international employment legislation.

  • Reasonable accommodations are provided per the Americans with Disabilities Act.


Summary

Manages and executes site identification and start-up processes across all clinical trial phases. Responsible for investigator contracts, regulatory submissions, collection and review of essential documents, and end-to-end site activation. Ensures timelines, budgets, and quality standards are met. May serve as the primary contact with regulatory authorities and ethics committees under supervision. Accountable to Project Lead/Site Activation Manager for deliverables.