Clinical Trial Document Specialist
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.
- 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
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.