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Study Start Up Project Delivery Manager

JOB SUMMARY

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. Accountablefor the delivery of activation-ready study sites on time, on budget, and incompliance with all applicable regulations. Responsible for overseeing all SiteStart-Up activities from site selection/recommendation through site-activationready. Develops integrated SSU timelines and reports weekly progress includingplans to address potential risks/gaps to the project team, Project Manager(PM), SSU Management and Project Sponsor.

JOB RESPONSIBILITIES

·Collaborateswith major functional area leads (SSU Country Managers, Project Management, andClinical Management) to identify and evaluate fundamental issues pertaining toSite Start-Up, project regulatory pathway, successful patient enrollment,interpret data on complex issues, make good business decisions, and ensuresolutions are implemented.Ensures allproject deliverables meet the internal and customers’ expectations as percontracted 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.

·Providesoversight of all project SSU deliverables which encompasses all activities fromsite selection through site activation ready.

·Assumesaccountability 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 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.

    ·Prepares and presents overall SSU strategy andstatus at client meetings and communicates outcomes to project team.

    ·Reviews the project SSU budget with thefunctional leads, project PM, and the SSU Business Unit Controller againstproject milestones and budget to ensure project profitability.Takes corrective measures where necessary tokeep project in line with budget and gross profit expectations.

    ·Uses professionally recognized tools forplanning and management of scope, timeline, resources, and ensures that minimumhours are used for tasks. If out-of-scope work is requested, notifies theproject PM and her/his SSU manager and track out of scope until assigned toback log.

    ·Prepares the core submission documents and coreclinical trial application dossier.

    ·Assistin development of master Patient Information Sheet (PIS) /Informed Consent Form(ICF) in collaboration with the PM and medical department.

    ·Oversees collation, quality review, andsubmission 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/approvaltimelines; if forecasted timelines are not reached or if any potential issue isidentified, solves or escalates the problem quickly. In parallel with projectdeliverables, identifies best practices and initiates/participates in processimprovement initiatives in conjunction with the global SSU leadership plan.

    ·Accountable for the negotiation and execution ofclinical trial agreements and budgets in accordance with agreed timelines. Includescoordination of internal and external stakeholders in the development and/orprovision of required clinical trial agreement templates and investigator sitebudgets, oversight of local contract negotiator colleagues and assistance inresolving negotiation barriers, and periodic progress reporting to the clientand other stakeholder groups. May include providing assistance and guidance toSSU Lead colleagues in their coordination of clinical trial agreementactivities.

    ·Participates in new business developmentactivities including participation at client presentations.Reviews proposals, attends clientsales-focused meetings, and provides information to support businessdevelopment activities.

    ·Actively participate in team meetings. Designspresentations and delivers information in a way that allows the audience tounderstand the information and interact appropriately.

    OtherResponsibilities:

    Ensureall relevant documents are submitted to the Trial Master File (TMF) as perCompany SOP/Sponsor requirements.

    Performsother work-related duties as assigned. Minimal travel may be required (up to25%) .


    Qualifications

    QUALIFICATION & REQUIREMENTS 

    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.


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