Syneos Health

Site Activation Manager – Logistic, Import & Export Experience

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: Argentina

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Tech Stack

Google Cloud Platform

About the role

  • 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
  • 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
  • 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

  • Bachelor’s Degree, Higher Degree Preferred
  • 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
  • We are passionate about developing our people, through career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program
  • Total Self culture – where you can authentically be yourself
  • continuous building of the company we all want to work for
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial processproject managementregulatory activitiesbudget managementrisk managementdata interpretationclinical protocolssubmission documentssite start-up processesvendor management
Soft Skills
organizational skillscommunication skillspresentation skillsinterpersonal skillsnegotiating skillsproblem-solving skillsquality-driven mindsetability to provide feedbackrelationship managementcollaboration
Certifications
Bachelor’s DegreeHigher Degree PreferredICH GCP certification