Company description
Onorach is a fast-paced, lean, and dynamic organisation delivering Phase I to IV Clinical Research Management services for drug products, medical devices, nutraceuticals and food supplements. We also provide innovative digital technology solutions accelerating clinical trial timelines and improving trial data quality.
Onorach is headquartered in Dundee, Scotland and has subsidiary businesses in Scotland and Latvia.
Clinical Project Manager - Job Outline
Onorach are inviting candidates who will be accountable for clinical projects success and performance ensuring timelines, specifications (quality, etc.) and budgets are met with high client satisfaction and service provided at every stage of the process.
The Project Manager (PM) role will entail but not be limited to:
• Study setup, supervision of setup activities, monitoring the conduction phase, and overseeing the project through to study closure.
• Provide technical support to the sales team in preparation of proposals.
• Acting as the principal contact to the sponsor’s operational personnel, and coordinating all project related activities internally and with external vendors.
• Monitoring all aspects of designated clinical trial protocols and being accountable for meeting agreed timelines, budgets, and specifications for deliverables.
• Monitoring of contract status and execution with sponsors and vendors.
• Delivering high project performance.
• Working to Good Clinical Practices (GCP). Candidates must hold or acquire ICH-GCP certification (renewed every 2 years).
• Supervising CRAs in their daily work and reviews visit reports and communications from CRAs.
• Occasionally the PM may be required to write protocols, case report forms, informed consent forms, patient information sheets and questionnaires.
• Writing and maintaining in-house Standard Operating Procedures (SOPs) for the clinical function.
• Providing guidance to the CTA in archiving and filing activities/
• PM will prepare and present presentations and manuscripts at scientific meetings and for technical journals if required.
• Occasionally the PM may need to work after hours or on weekends to complete proposals etc. and the PM will occasionally be expected to travel.
The PM needs to live within commuting distance of Onorach’s' Dundee office.
Candidates must also have:
• Full understanding of GCP, ISO 14155, EN540 and other relevant regulations.
• Experience with FDA, EMA or EFSA regulations.
• Experience of working in a quality system environment.
• Proven experience in using Microsoft Word, Excel, and PowerPoint.
• Proven ability in project set-up and management.
• Experience of writing clinical documentation.
Note: This PM role requires a minimum of 2 years’ clinical experience working at this level.
Reference ID: ONOCPMv2 Mar2021
Application deadline: 05/04/2021
Expected start date: 12/04/2021
Job Types: Full-time, Permanent
Salary: £35,000.00-£49,999.00 per year
Applications to christene.leiper@onorach.com with covering letter, confirmation of minimum experience requirements and a CV.