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Clinical Operations Manager

Employer
Warman O’Brien
Location
Basel, Canton of Basel-Stadt (CH), Basel
Salary
Competitive hourly rate
Start date
11 Jan 2022
Closing date
10 Feb 2022

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Contract
Experience Level
Management
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Job Details

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. 

Company

Warman O’Brien is a global specialist Life Sciences recruitment partner headquartered in London. We recruit across a number of functional areas including Biometrics, Clinical Research, Data Science, Bioinformatics, QA, Discovery Sciences and Translational Research, Procurement & Technical Operation across the UK, Europe and North America. We cover both temporary/contract and permanent vacancies for companies across the pharmaceutical industry.

Find Us
Website
Telephone
+44 (0) 2033255075
Location
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
GB
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