Site Activation Manager

Syneos Health

Site Activation Manager overseeing Site Start-Up deliverables for clinical trials in a hybrid role. Collaborating with cross-functional teams to ensure project timelines and regulations are met across various locations.

Posted 5/21/2026full-timeMorrisville • North Carolina • 🇺🇸 United StatesMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a country, region or globally, within the assigned projects or programs
Directs the technical and operational aspects of the Site Start-Up deliverables of the assigned projects
Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations
Responsible for overseeing all Site Start-Up activities from site selection/recommendation through site-activation ready and all maintenance activities for the life cycle of the study
Develops SSU timelines as required and reports progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor
Provides mentoring and/or oversight of less experienced Site Activation Managers
Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing
Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented
Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management
Develops and maintains relationships with customers in alignment with their assigned projects
Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed
Provides oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects
Assumes accountability on start-up deliverables including, but not limited to: Site Identification and selection
Start-up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions, study maintenance and amendment submissions)
Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any require amendments
Establishing and overseeing Essential Document collection leading to site activation
Overall SSU timelines, prior to and following site activation. Including any realignment required due to amendment needs
Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes
Complies all controlled document requirements and other requirements to ensure quality deliverables
Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps
Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team
Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability
Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations
Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management
Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects
Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams
Responsible for or assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department
Oversees collation, quality review, and submission of country-specific applications
Contributes to change initiatives across and within the SSU department
Other Responsibilities: Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Performs other work-related duties as assigned

Requirements

What you’ll need

Bachelor’s Degree, Higher Degree Preferred
Minimum 6 years CRO industry experience and/or a minimum 5 years’ experience working in a SSU, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job
Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
Good understanding clinical protocols and associated study specifications
Excellent understanding of clinical trial start-up processes
Project management experience in a fast-paced environment
Good vendor management skills
Strong organizational skills with proven ability to handle multiple projects
Excellent communication, presentation and interpersonal skills
Quality-driven in all managed activities
Strong negotiating skills
Strong problem-solving skills
Demonstrate an ability to provide quality feedback and guidance to peers

Benefits

Comp & perks

Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial processSite Start-Up (SSU)project managementregulatory activitiesclinical trial agreementsEssential Document collectionrisk managementbudget managementclinical protocolsICH GCP

Soft Skills

leadershipcommunicationpresentationinterpersonal skillsorganizational skillsnegotiating skillsproblem-solving skillsmentoringquality-drivenvendor management