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Clinical Operations Consultant

Employer
RBW Consulting
Location
Remote in Europe
Salary
Competitive Rate
Start date
31 Aug 2022
Closing date
30 Sep 2022

View more

Discipline
Clinical Research, Clinical Operations, Feasibility
Hours
Part Time
Contract Type
Contract
Experience Level
Senior Management

Job Details

Clinical Operations Consultant - Remote in Europe - Contract - 12 months (renewable) - 20 hours (to start with) - Pediatric Studies - Competitive Rate

RBW Consulting are excited to announce an opportunity on behalf of our close Biotech client with studies in phase II and phase IV of development. They are US-based and growing in Europe where they are conducting feasibility studies across 17 countries (in Europe and globally). This is a great opportunity to contribute to interesting pediatric studies and be pivotal to the companies success during this crucial stage of their research.

 

Job Summary:  

The Clinical Operations Consultant will ensure that clinical strategies are translated into operational plans for assigned studies. He/she works within the Clinical Operations Lead and with all involved functions and vendors, such as contract research organizations, and is involved with the selection and oversight of the Clinical Operations vendors.

My client may at any time ask the COC to perform other tasks and duties not outlined in this job description.

The COC must conduct their work activities in full compliance with defined expectations, including the company's Science’s internal requirements, GMP and ISO, and all other applicable health authority. The company's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives.

This document describes the major responsibilities of the job. It does not include all aspects of the position, such as the potential additional duties assigned by management, and the requirement for flexibility in assisting others for the company’s overall benefit.

Key Duties and Responsibilities: 

  • Collaborate with other xxx functional areas and the study vendors, oversee all aspects of the study activities and work to ensure the study timelines are being met
  • Attend and participate in study meetings and communicate any study issues that may arise, as well as any items that may impact in the study budget and timelines
  • Provides input into clinical study protocols, clinical study reports, and other clinical documents as appropriate on assigned studies. Contribute to the development of the Master Informed consent for clinical studies
  • To preparing, collecting, and tracking master study level documents (as appropriate); reviewing Regulatory and non-regulatory documents; reviewing and tracking monitoring visit reports and follow-up; reviewing, updating, and testing clinical systems; producing reports on clinical status, trends, and metrics; tracking and management of vendor invoices and Purchase Orders (POs)
  • Involved in internal process improvement activities such as SOPs or guidance documents, as assigned
  • Participate in the cross- functional TMF Review
  • Other responsibilities that may arise.

Minimum Requirements:

Education and Experience

  • Health or Biologics Science degree required.
  • At least 5+ years of experience in clinical development operations for global clinical trials. Clinical research experience will be very much appreciated.
  • Experience in managing a CRO /Other Vendor is preferred.

Essential Skills and Abilities

  • Good organizational skills
  • Good communication skills, both verbally and in writing
  • Good presentation skills
  • Ability to work across locations and time zones
  • Ability to work on multiple projects and assignments at the same time
  • Ability to prioritize tasks
  • Strong financial business acumen and analytical skills
  • Strong interpersonal skills and ability to manage vendors
  • Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1273 049 215

Please click ‘apply’ or contact Joe Pearce for any further information

About RBW Consulting

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

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