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 operationalaspects of the Site Start-Up deliverables of the assigned projects.Accountable for the delivery ofactivation-ready study sites on time, on budget, and in compliance with all applicableregulations.Responsible for overseeingall Site Start-Up activities from site selection/recommendation throughsite-activation ready.Developsintegrated SSU timelines and reports weekly progress including plans to addresspotential risks/gaps to the project team, Project Manager (PM), SSU Managementand 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 relationshipswith customers 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.
·Assumesaccountability on SSU deliverables including, but not limited to:
·Start-upregulatory activities (submissions, oversight of communication to competentauthorities/ethics committees, import/exportlicenses, study maintenance submissions);
·Oversight of delivery of executed clinical trialagreements and investigator budgets with investigator sites
·EstablishingEssential document collection leading to site activation;
·OverallSSU timelines to site activation.
·Develops plans in accordance with StandardOperating Procedures and/or sponsor-scoped process.Complies with all controlled documentrequirements and other requirements to ensure quality deliverables.
·Develops and manages integrated site start-uptimelines and reports weekly progress including plans to address potentialtiming risks/gaps.
·Work with the project leadership to define thestrategy to execute against milestones and key deliverables. Prepares andpresents overall SSU strategy and status at client meetings and communicatesoutcomes to project team
·Monitor team efficiency and adherence toproject timelines. Ensure quality of designateddeliverables. Responsible for drivingteam efficiencies with a goal of reducing waste and increasing SSU predictability.
·Develop, maintain and publish project KPI’sthat 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 andbudget to ensure project profitability.Takescorrective measures where necessary to keep project in line with budget andgross profit expectations.
·Usesprofessionally 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, notifiesthe project PM and her/his SSU manager and track out of scope until assigned toback log.
·Preparesthe core submission documents and core clinical trial application dossier.
·Assistsin development of Patient Information Sheet (PIS) /Informed Consent Form (ICF)in collaboration with the PM and medical department.
·Overseescollation, quality review and submission of country-specific applications.
·Accountable for the timely follow-up for EthicsCommittee/Competent Authority enquiries or objections in collaboration with thecountry SSU Specialists.Meets or exceeds the planned submission/approval timelines; if forecastedtimelines are not reached or if any potential issue is identified, solvesor escalates the problem quickly.Inparallel with project deliverables, identifies best practices andinitiates/participates in process improvement initiatives in conjunction withthe global SSU leadership plan.
·Accountable for the negotiation and execution ofclinical trial agreements and budgets in accordance with agreed timelines.Includes coordination of internal and external stakeholders in the developmentand/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. May include providingassistance and guidance to SSU Lead colleagues in their coordination ofclinical trial agreement activities.
·Developsnew business opportunities whenever possible (e.g., while in attendance atprofessional conferences/seminars), participates in new business developmentactivities including participation at client presentations.Reviews proposals, attends client sales-focusedmeetings, and provides information to support business development activities.
·Activelyparticipate in team meetings. Designs presentations and delivers information ina way that allows the audience to understand the information and interactappropriately.Designs and deliversbasic training courses.
·Maybe recognized as a subject matter expert in specific regulatory areas(pediatric studies, advanced therapy products, medical devices, etc.) and/or indevelopment and review of Standard Operating Procedures (SOPs) and WorkInstructions (WI) to support new or existing processes.
Ensureall relevant documents are submitted to the Trial Master File (TMF) as perCompany SOP/Sponsor requirements.
Performs other work-related duties as assigned. Minimal travel may berequired (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.