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Job Details

Clinical Trial Transparency Analyst

Company: Docs Global (Continental Europe)
Location: warszawa,Poland
Reference: Ref AS-024035
Closing Date: 20 Mar 18
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS is supporting highly prestigious and one of the world’s top pharmaceutical company that is bringing innovative ideas, products and services continuously improving people’s health. This is a fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge, further develop their career and enjoy working culture in vibrant Client's office in Warsaw.


Roles & Responsibilities of the position

The CTT Operations Analyst will lead the anonymization of clinical study documents in support of EMA policy 0070 and other disclosure of clinical documents that must be redacted or anonymized. The Analyst is accountable for taking original clinical study documents and anonymizing them using the latest tools and industry best practices. This role will have in-depth understanding of the EMA Policy 0070 and other similar global policies. The ideal candidate understands clinical study data and clinical study reports. The ideal candidate would have experience working with this data to create clinical study reports. The ideal candidate will have expertise in using systems and proven track record for attention to detail.

1. Be the CTT system expert in the use of Technology Tool for delivery of Redacted Clinical Packages.
2. Understands the data collected and used in the Clinical Study lifecycle from site through to Clinical document authoring.
3. Work closely with the Business Solutions Team on Risk Measurement and quantification of data sets, particularly focused on those used for delivery of EMA policy 0070 Redacted Document Packages
4. Accountable for good Information Practice on all assigned activities
5. Create anonymized clinical documents following best practices and established SOPS.
6. Contribute to the anonymization report for the reports created.
7. Support development of any training materials as needed in collaboration with direct manager.
8. Ensures adherence to all applicable requirements.
9. Demonstrates a high focus on quality and the ability to meticulously quality check work delivered.
10. Establish best practice to improve quality, efficiency and effectiveness

Job Requirements

- Previous experience of working in clinical research industry
- Understanding of the design of clinical study reports and clinical study data
- Knowledge of a statistical or database programming language (preferably SAS, R).
- Good understanding of Global Medicines Development
- Proficient in speaking and writing the country language and English. Good written and oral communication skills.
- Be able to work office-based in Warsaw

Remuneration & other details

We offer:
· Competitive salary
· Work in the global organization in Poland
· development opportunities with rapid growing organization

To apply:

If you have a previous experience in clinical research and have a knowledge of statistical and programming languages such as: SAS or R, please email your CV to:

About DOCS:
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.

Key words:
SAS, SAS Programming, R, Clinical Study Report, CRO, Transparency, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland

Apply for this job: Clinical Trial Transparency Analyst

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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