Associate Director, Project Management Country

vor 3 Wochen

Munich, Deutschland AstraZeneca Vollzeit

**This is what you will do**: The AD Project Management Country Operations (AD PMCO) is responsible for the successful execution of study deliverables and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and consistency of monitoring activities.The AD PMCO is accountable for coordinating rapid start up activities across assigned countries together with the CRO. The AD PMCO will also drive adherence to timelines and milestones of study goals as well as identifying and communicating risks to the study team. The AD PMCO will ensure that the CRO assigned, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues. Works with the CRO to revise study specific country plans and timelines.

Accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations. Ensures that the studies assigned in the country are appropriately resourced. The AD PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocolspecific training. Attendance at site visits as required together with the CRO, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Sponsor Oversight, Inspection Readiness or Engagement Visits.

**You will be responsible for**: Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies)Proactive reporting of studyspecific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO)Quality of monitoring oversight in the country for assigned study(ies)Meeting recruitment targets for assigned study(ies)CDA delivery and negotiation (based on preapproved parameters and regardless of executory party)Negotiation of site study budgetsOversight of FSP and /or contingent workers on assigned study(ies)Review of local regulatory documentation and oversight of local regulatory activitiesRelationship management with the national coordinating investigator as applicable You will need to have: Bachelors Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.8+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred. Proven experience in the oversight and delivery of operational aspects of all stages of clinical trial processSolid knowledge of clinical development processesA track record of ensuring GCP compliance and successful risk management of complex clinical studies is expectedProven experience in effectively communicating with site staff including KOLs and thought leadersComprehensive and current regulatory knowledge, including GCPExperience conducting GCP or other training is a plusDemonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods)Good organizational skills and ability to deal with competing prioritiesEffective communication skills (written, verbal and presentation)Creative thinker, curious and unafraid to ask questionsInnovator, willing to initiate changes, introduce new ideas, and creatively solve problemsProficient with MS Office Suite (Excel, Word and PowerPoint) We would prefer you to have: Ability to lead, troubleshoot and influence for quality and deliveryProven experience in managing high priority / complex studies through phases 1 4 and in rare medical conditions preferred (inhouse delivery)Previous oversight and regulatory inspection experience preferred Proactivly and assertively communicate communicating with internal stakeholders and sites Ability to work in an environment of remote collaborators Able to work in a matrix reporting structure Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the businessAbility to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less timeDemonstrates ability to prioritize and manage multiple tasks with conflicting deadlinesProactivly and assertively communicate with internal stakeholders and sites Familiar with riskbased monitoring approach including remote monitoringAbility to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an eenabled environmentTeam oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Experience in all study phases and in rare medical

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