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.
- 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.
- Work with the project leadership to define the strategy to execute against milestones and key deliverables. Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team
- Monitor team efficiency and adherence to project timelines. Ensure quality of designated deliverables. Responsible for driving team efficiencies with a goal of reducing waste and increasing SSU predictability.
- Develop, maintain and publish project KPI’s that track project quality, delivery and predictability
- Provides oversight of the scope of work, budget and resources. 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.
- Assists in development of 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.
- Develops new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), 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. Designs and delivers basic training courses.
- May be recognized as a subject matter expert in specific regulatory areas (pediatric studies, advanced therapy products, medical devices, etc.) and/or in development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes.
- 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. Minimal travel may be required (up to 25%).
QUALIFICATION & REQUIREMENTS
- Bachelor’s Degree, Higher Degree Preferred. Minimum 6 years CRO industry experience and/or a minimum 5 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 10 studies from award and into maintenance; at least 3 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.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job .