Clinical Documentation Specialist
- Employer
- Hyper Recruitment Solutions
- Location
- London
- Salary
- Experience Dependent
- Closing date
- 26 Sep 2019
View more
- Sector
- Biology, Biotechnology, Clinical Research / Trials , Quality Assurance
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Documentation Specialist will be varied. However, the key duties and responsibilities are as follows:
1. You will plan, perform and follow up internal and external audits of paper and electronic TMFs to ensure compliance to quality standards, raising any compliance gaps.
2. As the Clinical Documentation Specialist, you will write controlled documentation and ensure all documentation is appropriately processed in the eTMF for ongoing review of their quality standards.
3. You will ensure all controlled paper documentation is archived and maintain an inventory to ensure submission and inspection readiness.
4. As the Clinical Documentation Specialist, you will be the point of contact for intra and inter business teams in the maintenance of TMFs and you will train staff on the regulatory requirements of the controlled documentation.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Clinical Documentation Specialist, we are looking to identify the following on your profile and history:
1. Relevant Life Sciences degree.
2. Proven industry experience in TMF document management, TMF audits and training staff on TMF regulatory requirements.
3. A working knowledge and practical experience with GCP regulatory requirements.
Key Words: Clinical Documentation | QA | Quality Assurance | TMF | Trial Master File | eTMF | Electronic Trial Master File | GCP | Good Clinical Practice | ATMP | Advanced Therapy Medicinal Products | Cell and Gene Therapy | CRO | Clinical Research Organisation | Auditing | Documentation
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Company
Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.
Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.
Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.
We provide services across a broad range of industries including the following specialist sectors:
• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science
With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:
• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments
HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.
Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com
Or any of the social media routes below:
Twitter
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
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