Ssu Project Delivery Lead

**Description**

**JOB TITLE: Site Start-Up Project Delivery Lead**

**SELECT ONE: Clinical Solutions**

**JOB CODE**:SH2313**

**JOB FAMILY**:
**BUSINESS UNIT**

**(COMMERCIAL ONLY)**:
**REPORTS TO**: Associate Director, Site Start-Up & Regulatory or designee**

**JOB SUMMARY**:
Responsible and accountable for the customer-focused leadership and management 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 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. Develops integrated SSU timelines and reports weekly progress including plans to address potential risks/gaps to the project team, 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 with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets and client 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.
- Assists in development of master Patient Information Sheet (PIS) /Informed Consent Form (ICF) in collaboration with the PM and medical department.
- 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 and execution of clinical trial agreements and budgets in accordance with agreed timelines. Includes coordination of internal and external stakeholders in the development and/or provision of required clinical trial agreement templates and investigator site budgets, oversight of local contract negotiator colleagues and assistance in resolving negotiation barriers, and periodic progress reporting 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 informatio