SSU Project Delivery Lead
Syneos Health
Hong Kong
2天前

JOB SUMMARY

Responsible and accountable for the customer-focused leadership andmanagement of Site Start-Up (SSU) deliverables within a region or globally,within the assigned projects or programs.

Directs the technical and operational aspects of the Site Start-Up deliverablesof the assigned projects.Accountablefor the delivery of activation-ready study sites on time, on budget, and incompliance with all applicable regulations.

Responsible for overseeing all Site Start-Up activities from siteselection / recommendation through site-activation ready.

Develops integrated SSU timelines and reportsweekly progress including plans to address potential risks / gaps to the projectteam, Project Manager (PM), SSU Management and Project Sponsor.

JOB RESPONSIBILTIES

  • Collaborates with major functional area leads (SSU Country Managers, Project Management, Clinical Management,) to identify and evaluate 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 assessments.

  • Develops and maintains relationships withcustomers in alignment with their assigned projects. May collaborate with business leads for businessdevelopment, alliance management, contracts and proposals development, projectmanagement, and clinical management to achieve project goals.
  • Ensures that individual project targets andclient needs are met, services are provided with the highest quality standards,and policies and procedures are followed.

    Contributes to change initiatives across and within the SSU department.

  • Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.
  • Assumes accountability on SSU deliverables including, but not limited to :
  • Start-up regulatory activities (submissions, oversight of communication to competent authorities / ethics committees, import / export licenses, study maintenance submissions);
  • Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites
  • Establishing Essential document collection leading to site activation;
  • Overall SSU timelines to site activation.
  • 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 minimum hours are used for tasks.
  • If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log.

  • Prepares the core submission documents and core clinical trial application dossier.
  • Assists in development of master Patient Information Sheet (PIS) / Informed Consent Form (ICF) in collaboration with the PM and medical department.
  • Oversees collation, quality review, and submission of country-specific applications.
  • Accountable for the timely follow-up for Ethics Committee / Competent Authority enquiries or objections in collaboration with the country SSU Specialists.
  • Meets or exceeds the planned submission / approval timelines; if forecasted timelines are not reached or if any potential issue is identified, solves or escalates the problem quickly.

  • Accountable for the oversight of negotiation andexecution of clinical trial agreements and budgets in accordance with agreedtimelines.
  • Includes coordination of internal and external stakeholders in thedevelopment and / or provision of required clinical trial agreement templates andinvestigator site budgets, oversight of local contract negotiator colleaguesand assistance in resolving negotiation barriers, and periodic progressreporting to the client and other stakeholder groups.

  • Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
  • Participates in new business development activities including participation at client presentations.Provides information to support business development activities.
  • Other Responsibilities :

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

    Performs otherwork-related duties as assigned. Minimaltravel may be required (up to 25%).

    Qualifications

    QUALIFICATION & REQUIREMENTS

    Bachelor’s Degree, Higher Degree Preferred. Minimum 4 years CRO industry experience and / or a minimum 3 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.

    Experience with leading / co-leading at least 5 studies from award and into maintenance; at least 2 of those studies must have included more than 10 countries across multiple regions.

    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 Contribute to a training and Quality assurance plan within SSU and update SOPs / WI.

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