Clinical Research Manager

Highly Competitive
  1. Permanent
  2. CRA Manager
  3. Belgium
Beerse, Belgium
Posting date: 17 Mar 2020
28559

A leading Clinical Stage gene therapy company focused are currently hiring a Clinical Research Manager. Based in Belgium, this incredible organisation is offering a bright and dynamic individual an opportunity to bring their expertise to an established company while changing the face of medicine.

Job Responsibilities

  • Assist Therapeuthic Area (TA) leaders and Pharmacometrics Group Leaders with portfolio management meetings to plan and manage the portfolio from a resource.
  • Budget perspective in alignment with Project Management Office (PMO) Lead and compound development strategy.
  • Establish timelines to support compound development plans, consistent with overall business plan in collaboration with Project Management personnel
  • Represent CPP in cross-functional working groups per compound, and other non-trial-specific project-related meetings, to provide input regarding project or submission deliverables.
  • Management of Clinical Pharmacology trials. Take lead in the planning and outsourcing of Clinical Pharmacology deliverables within different therapeutic areas.
  • Assure that timelines are met and follow up on changes in scope, timelines, budget and Quality and report to the relevant parties.
  • This role requires a working experience with SharePoint, Excel, and an in-depth knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities.
  • Closely follow up on timely execution and finalization of contracts/work orders with External Service Providers/vendors, in partnership with Janssen R&D Procurement.
  • Carry out functional responsibilities in accordance to applicable SOPs and Regulatory requirements.

Skills and Responsibilities

  • B.S, M.S., PharmD or equivalent with 4 years of industrial experience or CRO experience in areas of Drug Development is required.
  • Experience managing cross-functional teams is required.
  • Experience working with External Service Providers is preferred.
  • Working knowledge of functional planning systems, tools and OOPs algorithms is preferred.
  • Experience with SharePoint, Excel and ARIBA is preferred.
  • Ability to communicate effectively, verbally and in writing, to individuals and groups at various levels in the organization is required.
  • Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required.

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Luke Saner at +443300524502 or upload your CV on our website - www.proclinical.com

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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