SSU Project Delivery Lead/ Contract experience. Madrid. Sponsor dedicatedUpdated: September 25, 2024
Location: Spain-Europe - ESP-Home-Based (Madrid)
Job ID:24005188
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Job responsibilities
• 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:
o Start-up regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses, study maintenance submissions);
o Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites;
o Establishing Essential document collection leading to site activation;
o 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 backlog.
• 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 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 information to support business development activities.
Qualifications What we're looking for
• 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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.
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