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CLINICAL TRIAL MANAGER

Employer
Empatico
Location
Europe home working
Salary
Very competitive
Start date
10 Jun 2022
Closing date
10 Jul 2022

Job Details

Who Will You Be Working For?

This is an in-sourcing role, you will be employed by our client, who is a Global CRO but working within the Pharmaceutical company.  They have strong values and a real passion for what they do.  Recognising that it is their people who make them the success they are, this company focuses on teamwork whilst promoting a positive work/life balance.  They always have a desire to keep seeking new and better ways to operate. They don’t settle for the same old ways. Their passion for improving patient lives worldwide permeates all that we do. Put simply, they care.

General Summary

As a Clinical Trial Manager, you will be dedicated to one of our global clients, a global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer.  The Clinical Trial Manager will be responsible for the execution of clinical trial site monitoring functions of a clinical trial, management of staff (direct or indirect) within the Clinical Trial Management Team, and development of standards and practices within the clinical trial management group.

 Responsibilities:

  • Acting as Protocol Lead on one or more clinical trials and serving as the main point of contact for clinical site management and clinical trial site monitoring functions.
  • Participating as a member on assigned cross functional study team.
  • Assisting with the design and review of study documents: informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups.
  • Participating in the Clinical Protocol Committee as appropriate.
  • Developing or providing clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate.
  • Leading identification, evaluation and selection of clinical trial investigators/sites.
  • Managing clinical trial site monitoring team metrics to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals.
  • Coordinating and managing vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organisations (CRO).
  • Ensuring completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies.
  • Leading functional teams within the Clinical Trial Management department.
  • Managing internal (dotted line or functional) and Field CRAs, and other external clinical trial service vendors as necessary. Providing timely feedback to assigned staff on personal and project-specific performance and providing guidance on performance improvements as necessary.
  • Performing performance evaluations and ensuring staff training is adequate and documentation of training is up to date.
  • Assuming responsibility for development and maintenance of department SOPs or processes and ensuring assigned team adheres to them.
  • Becoming a subject matter expert for complex processes within the clinical trial management team.
  • Ensuring assigned team (dotted line or functional) adheres to clinical operations or project-specific quality documents (e.g., SOPs, work practices, training guides). Leading department initiatives that drive process improvement

 As a Clinical Trial Manager, you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients’ lives.  You are passionate and responsible. 

The company wants their employees to succeed, and they enable this success through consistent training, development, and support.

To be successful in this position you will have:

  • Strong interpersonal skills, organisational skills and ability to lead
  • Ability to manage multiple priorities simultaneously
  • A quality-focused mindset
  • 6 + years of experience in a similar role at a CRO or pharma company
  • Strong experience working in oncology clinical trials from phase I to III
  • Bachelor’s degree or Master’s degree or equivalent / PhD or MD
  • Fluency in written and spoken English

The company is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

 

Company

We are a boutique, recruitment and selection company, specialising in three, bespoke offerings:

  • Executive retained search, where we will source, highly competent and fully screened candidates to fit your executive role perfectly;
  • Contingent recruitment where we will apply our significant experience and proven processes to produce a pre agreed number of qualified candidates for you to choose from;
  • Consultancy, where Empatico offers wide ranging HR and people management expertise, tapping in to our wide ranging and diverse associate talent pool, in order to provide you with the appropriate skills and experience to advise, guide and coach you towards your business goals and desired outcomes.

 

As our name would imply, our approach is to partner with our clients, over the long term, so that we are embedded in your business, understand your business drivers and challenges and are, therefore better able to source individuals that will fit with your culture and become high performers, over the long term.

Company info
Website
Telephone
02035877618
Location
1 Empire Mews
The Hideaway Workspace
London
Greater London
SW16 2BF
United Kingdom

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