Clinical Operations Manager

☞ PharmiWeb.Jobs

Ver: 196

Dia de atualização: 20-03-2024

Localização: Basel Basel-Stadt BS

Categoria: Gestão executiva Produção / Operação

Indústria: Research Services Biotechnology Research Pharmaceutical Manufacturing

Posição: Mid-Senior level

Tipo de empregos: Full-time

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Conteúdo do emprego

An experienced Clinical Operations Manager is required to join our client, a well established pharmaceutical company on an initial 12 month contract. This position will be based near Basel, with some home-working allowed due to COVID restrictions.

What You Will Be Doing
  • Manage the operational trial related activities, including site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards, completion of (eCRFs), Source Data verification (SDV) progress and query responses timelines
  • Lead the development of specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables
  • Supervise the deliverables towards the (CRO) and service providers selected for the trial, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to the Clinical Trial team
  • Lead the development of trial-related operational documents
  • Consolidate information on operational clinical trial level activities for reporting to the clinical trial team by the Senior Clinical Operations Manager (including critical issues and key performance indicators)
  • Act as the communication channel for the (CRAs) to ensure data quality is maintained, in close collaboration with other clinical trial functions
  • Approve invoices (e.g. site payments) and ensure related payments in a timely manner
  • Contribute to the Study Master File completeness and readiness for audit/inspection and by performing ongoing quality checks/review
  • Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary
What You Can Bring To The Role
  • 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report
  • Experience in working in global cross-functional (matrix) and multicultural teams
  • Experience in selecting and managing external service providers, including performance assessments and finance management
  • Previous experience working with electronic data capture, eTMF, and Clinical Trial Management Systems
  • Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
What You Get In Return
  • The opportunity to work for a global pharmaceutical company on a contract basis
  • Exposure to global clinical trials
  • Competitive hourly rates
What To Do Next
  • Please apply now for a confidential discussion on this opportunity.
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Data limite: 04-05-2024

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