Global Study Start Up Project Delivery Manager - single sponsor studies at Syneos Health Clinical Solutions

Job Responsibilities

• Collaborates with major functional area leads (SSU Country Managers, Project Management, and 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 strategic 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 process. Complies with 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, project PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and gross profit expectations.
• Uses professionally recognized tools for planning and management of scope, timeline, resources, and ensures that minimum hours are used for tasks. If out-of-scope work is requested, notifies the project PM and her/his SSU manager and track out of scope until assigned to back log.
• Prepares the core submission documents and core clinical trial application dossier.
• Assist 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. In parallel with project deliverables, identifies best practices and initiates/participates in process improvement initiatives in conjunction with the global SSU leadership plan.
• Accountable for the 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. May include providing assistance and guidance to SSU Lead colleagues in their coordination of clinical trial agreement activities.
• Participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities.
• Actively participate in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately.

Qualifications

What we’re looking for

• Bachelor’s Degree, Higher Degree Preferred. Minimum 5 years CRO industry experience and/or a minimum 4 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 at least 7 studies from award and into maintenance; at least 2 of those studies must have included more than 15 countries across multiple regions. Experience with at least one of the following trial types: pediatric, medical devices, bioequivalence, advanced therapy products, or vaccines.
• 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.
• Strong leadership skills; ability to teach/mentor team members. Strong ability to analyze data and make appropriate decisions.