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Clinical Operations Manager

Employer
Warman O’Brien
Location
Canton of Basel-Stadt (CH), Basel
Salary
Competitive hourly rate
Start date
14 Jun 2022
Closing date
12 Jul 2022

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

Job Details

An experienced Clinical Operations Manager is required to join a global pharma on an initial 12 month contract. Based onsite near Basel, the successful candidate will be responsible for driving the development of the operational trial related documents and procedures, as well as setting-up the vendors and supervising the deliverables of all vendor related activities, from specifications to close-out.

Responsibilities will include:

  • Manage the operational trial related activities in close collaboration with other functions, such as: 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 (ECs/IRBs), timely completion of electronic Case Report Forms (eCRFs), Source Data verification (SDV) progress and query responses timelines
  • Manage the selection of vendors in collaboration with other functions Lead the development of vendor specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables
  • Supervise the deliverables towards the Contract Research Organization (CRO) and vendors 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 (CTT) Lead the development of trial-related operational documents
  • Contribute to the Study Master File (StMF) 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
  • Mentor team members as needed

What you can bring to the role:

  • Bachelor of Science degree or equivalent University degree in life sciences or healthcare 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, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS) Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
  • Applicants must be legally entitled to work in Switzerland  - EU/EFTA Citizen (except UK) or Valid Swiss Work Permit 

What you get in return:

  • A 12 month contract with a global pharma
  • The opportunity to work with an experienced and dedicated team
  • Competitive hourly rates

To arrange a confidential discussion, please apply now with an updated CV

 

Company

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Warman O’Brien is a global specialist Life Sciences Recruitment Partner across the UK, Europe, USA and APAC. We recruit top talent across a number of functional areas including:

  • Biometrics
  • Data Sciences
  • Quality Assurance
  • Regulatory Affairs
  • Clinical Research
  • Discovery Sciences
  • C-Suite
  • Medical Affairs

We cover contract and permanent vacancies, executive search, and SOW for companies across the pharmaceutical industry.  

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Find out more on our website warmanobrien.com/

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Company info
Website
Telephone
+44 (0) 2033255075
Location
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
United Kingdom

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