Clinical Trial Document Specialist job in London, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Clinical Trial Assistant (CTA)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

A unique opportunity has arisen for a Clinical Trial Document Specialist to join a biotechnology company. The home-based role is the perfect chance to combine your experience and expertise to help the development of medicine worldwide.

Job Responsibilities

Participate in the set-up and maintenance of expected documents in our systems across multiple studies.
Ensure that TMF filing is consistent with established processes and TMF specifications by reviewing and imputing into study TMF plans
Perform routine oversight quality checks of documents uploaded into the TMFs by CROs and other Vendors for trends, quality, and completeness
Establish study specific internal QR reviews of TMFs to ensure compliance and inspection readiness and drive to completion.
Provide support and feedback to study teams and vendors on resolution of Quality issues
Participate in filing/initial QC and classification of documents into TMFs where necessary.
Communicate internal quality findings regarding TMF contents to study team members
Perform activities associated with TMF business needs including study management, user account management, system configuration support, TMF migrations

Skills and Requirements

Bachelor's degree, preferably in a scientific discipline, is required
Minimum of 4 years of experience in the pharmaceutical industry
Demonstrated proficiency with TMF Management. A minimum of 2 years of experience with our internal systems software
Must have strong knowledge and experience with the DIA Reference Model for TMFs
Working knowledge of clinical research documents
Demonstrated current knowledge of ICH, GCP, and other regulatory guidance's as applicable to management of clinical documentation
Ability to work in an extremely fast-paced environment with changing priorities
Ability to work collaboratively and cross-functionally
Attention to detail and accuracy in work

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 02074400639 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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