• Poland
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  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

The Clinical Trial Transparency team within Oncology R&D/ Chief Medical Officer organization leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally

The CTT Anonymization Analyst will process clinical study documents in support of Health Canadas PRCI process, EMA policy 0070 and other disclosure of clinical documents that must be redacted or otherwise anonymized The individual is accountable to anonymize submission clinical study documents and associated study data using the latest tools and industry best practices This role will require an in-depth understanding of associated regulatory policies, privacy, clinical data and documents

The ideal candidate possesses the following

a strong understanding of clinical study datasets, clinical documents (CSR, CSP, SAP) and outputs (TLFs)
experience working with data to create Clinical Study Reports (CSRs)
expertise in using systems and an interest in using the latest technology to achieve challenging tasks
proven track record for attention to detail
strong analytical and reviewing skills
proven track record for looking at innovative ways to solve problems
scientific background is beneficial
understanding SAS programming language is an advantage

This role will work globally with individual study teams to deliver anonymized documents for regulatory submission and data sharing This role will NOT manage the submission; they will provide submission ready deliverables to regulatory submission teams The role will be an individual contributor

Typical Accountabilities and required competencies

Create Anonymized Clinical Documents following best practices and established SOPs
Contribute to the Anonymization Report for the reports created
Be a system expert in the use of Technology Tool for delivery of Anonymized Clinical Documents
Perform System User Acceptance testing (UAT) as needed to grow the key tools used to do this job
Understands the data collected and used in the Clinical Study lifecycle from site through to Clinical Document authoring
Work closely with the Biometrics Data Operations Anonymization Team on Risk Measurement and quantification of datasets
Accountable for good Information Practice on all assigned activities
Maintain high level of understanding of regulatory policies and support protection of personal information
Support development of any training materials as needed in collaboration with direct manager
Ensures adherence to all applicable AstraZeneca requirements
Demonstrates a high focus on quality and the ability to meticulously quality check work delivered
Work with a continuous improvement mindset, looking for opportunities to improve the process and increase delivery efficiencies as this capability grows

AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills We believe that the more inclusive we are, the better our work will be We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements

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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Quality Assurance/Testing
Salary : As per Industry Standards
Deadline : 10th Mar 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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