Project Manager - Fsp/Nis Study Delivery Lead

Detalles de la oferta

.**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeClient Job Description:NIS Study Delivery LeadThis position combines end-to-end design, execution, and reporting of clinical studies and trials including:- Non-interventional studies using primary data collection, including prospective studies enrolling patients and / or HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.G. with EMRs / chart abstraction), patient reported outcomes development and validation.- Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence / incidence studies of exposure, risk factors and outcomes.- Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients.- Economic modelling studies and supplemental analyses of clinical trials / meta-analyses.- Interventional and low-interventional studies.Key attributes include scientific credibility, demonstrated ability to provide input on and influence studies / projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change and curiosity.This includes responsibility and / or accountability for the set-up, coordination, execution and delivery of studies in partnership with the Science Lead:- Planning and leading the delivery of NIS to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.- Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.- Accountable for the study delivery strategy (e.G. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms / tools etc).- With the majority of NIS fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.- Ensure compliance with ICH / GCP & ENCePP guidelines and/or applicable guidelines for studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.- Make decisions which balance risk / benefit with clear understanding of the impact on the study and project; acts to mitigate risk where appropriate.- Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.- Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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