Clinical Trial Manager, Clinical Operations
Shionogi Inc. - Florham Park, NJ
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OverviewResponsible for overseeing and managing insourced or outsourced studies including all operational aspects of assigned phase I - IV clinical trial(s), whilst ensuring patient safety, data quality and integrity.ResponsibilitiesResponsible for operational execution of global/regional Phase I-IV studies in accordance with budget and timeline. Manages trial deliverables as well as CRO and vendor relationship and performance. Drives the development of outsourcing specifications for vendor requests for proposal, leads vendor selection and oversees vendor management throughout the life of assigned clinical trial(s).Contribute to setting up and negotiating Task Orders as well as scope change negotiations. Oversees overall study level budget and appropriate invoices for all vendorsOversees study activities including study start-up, close out, and completion of Trial Master File. Ensures oversight of clinical trials including the selection of investigational sites, adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with study/ site personnel. Monitor all vendors/ CRO performance, communicate vendor expectations, and track vendor performance metricsResponsible for overseeing negotiation of site CTAs in conjunction with the Legal Department and CRO/contracts vendorResponsible for assessing resource requirements (time, financial manpower) for assigned study (ies)Manages study tasks and responsibilities directly or through effective delegation to other team members assigned to the study (ies).In collaboration with the CRO/vendor oversees operational study level feasibility, recruitment and retention strategies and the delivery of the study protocolProvides review of and input to selected study clinical documents (protocol, operational plans, monitoring plans, monitoring visit reports, etc) based on SOP, ICH/GCP guidelines and with patient centric viewResponsible for overall risk management of study to assure timely delivery to quality, budget and time. Escalates issues to stakeholders as appropriate and ensures successful implementationLeads or supports inspection readiness activities. Participates as appropriate in internal and external audits. Facilitate internal audit/corrective and preventative action (CAPA) management and contributes to the resolution of CAPAPlans and conducts study related meetings including investigator meetings and ad collaboration with data management, facilitates ongoing data review for trends and quality and in preparation for interim, final analyses and review of CSRResponsible for providing program director regular status updatesEstablish and maintain effective communication and collaboration with functional area peers in order to meet program objectives, proactively identify study risks and support achievement of goalsParticipates in SOP development as reviewer of local or global documents. Supports development and improvement of departmental and company procedures and shares best industry practiceMentor project team members regarding project specific activities, reporting and toolsOther duties as assignedSupervisory Decision Making AbilityDecision making for conduct of assigned study(ies) in accordance with company SOPsMinimum Job RequirementsBA/BS in life sciences or equivalent; At least 4 years of clinical research experience including at least two (2) years having effectively led a study/studies project from inception to completion coupled with demonstrated ability to hold team members accountable. Global experience of drug development ideally obtained in a biotech/pharma settingWorking knowledge of Good Clinical Practices (GCP), EU Clinical Trials Directive / Regulation and expectations for MHRA GCP Inspections. Awareness of FDA regulations and guidelines with respect to clinical trials, and applicable international regulatory requirementsKnowledge of clinical operations, project management tools and processes. Ability to effectively manage interactions with investigators ensuring cooperation for achieving program goalsKnowledge of pharmaceutical business, drug development and regulatory processesAbility to resolve problems and lead projects of diverse scope, analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior managementProficient MS Office skills including data review analysis toolsAbility to travel up to 10% including possible international travelPreferred Skills & ExperienceStrong written and verbal communication skills along with excellent interpersonal skills and proven ability to interface effectively with diverse development teamsPrior global experienceAbility to effectively multi-taskAttention to detail and accuracy in workStrong decision-making skills and ability to use independent judgment to quickly set priorities solve problems and resolve conflict.Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.Essential Physical RequirementsAbility to articulate clearly and conduct verbal presentations with large and small audiencesAbility to travel via automobile and/or airplaneAbility to view video display terminal imagesAbility to operate a computer keyboard and telephoneAbility to sit for extended periods of time - up to four (4) hours at a timeAbility to lift, tug, pull up to fifteen (15) poundsEEOShionogi Inc. is an equal opportunity/affirmative action employer.All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual...Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
Created: 2024-09-23