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Job Details

Data Surveillance Analyst

Company: PAREXEL
Location: Warsaw, Masovian Voivodeship,Poland
Reference: 43541BR
Closing Date: 22 Jun 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

Job Context:The role will be part of the Global Clinical Operations, acting as a Data Surveillance Analyst. The role will perform analysis of specific scientific and operational data to support the Data Surveillance process and will perform a central review of the defined project specific Quality Tolerance Limits. ...

Requirements:

Job Context:

The role will be part of the Global Clinical Operations, acting as a Data Surveillance Analyst. The role will perform analysis of specific scientific and operational data to support the Data Surveillance process and will perform a central review of the defined project specific Quality Tolerance Limits. The role will support the specific project functional roles with their DS Plan defined project reviews and any relevant findings will be communicated to the project team during the regular project specific Data Surveillance meetings. In addition, the role will support the development of the Data Surveillance Plan and participate in the Data Surveillance meetings.
Data Surveillance Analysts not only need to understand GCP and have a background in life sciences, but should also demonstrate fluency in statistical, analytical, and business skill sets in order to interpret risk (both qualitatively and quantitatively) and strategically support Data Surveillance activities. All reviews and analysis will be conducted as per the Data Surveillance Plan as aligned with Data Surveillance related processes, SOPs, ICH and/or other guidelines to fulfill local regulations.

Key Accountabilities:

Study Phase Accountability & Supporting Activities may include but not limited to the following:

Start-Up Act as PAREXEL’s Data Surveillance Analysis expert

• Support the development of a robust Data Surveillance Plan, Quality Tolerance Limits and Data Surveillance Applications (where relevant).
• Maintenance and close out Act as PAREXEL’s Data Surveillance Analyst, assess and review available study data to identify data quality trends, outliers, lack of variability, breeches of Quality Tolerance Limits, and other risks to study data quality and overall integrity.
• Review relevant data in via the Data Surveillance application, and/or other relevant reports, systems (DDM Application, MyTrials Analytics) and listings, as required to support reviews designated for the Central Data Surveillance Reviewer per the project specific Data Surveillance Plan, including project specific Quality Tolerance Limits.
• Document findings from Data Surveillance activities in the DS Findings Form, Issue Tracking system(s) and other as directed.
• Review relevant country level information in via the Data Driven Monitoring application, and/or other relevant reports, systems and listings, per the project specific Data Surveillance Plan.
• Review the relevant data in the Data Surveillance and/or Data Driven Monitoring application(s) and track the data with respect to the project specific Quality Tolerance Limits.
• Initiate creation of project level issues as appropriate relating to the Data Surveillance review findings.
• Participate in regular Data Surveillance meetings and communicate findings from Data Surveillance reviews.
• Provide feedback on technology to support updates to the Data Surveillance application and the DDM application.
• Actively participate in other external or internal meetings and audits & regulatory inspections as required.
• Recognize impact of study non-compliance/issues/delays/data quality signals/possible misconduct and communicate promptly escalate to FL any site and/or study issues that require immediate action.

Overall Accountabilities from Site identification to Close out Ensure timely and accurate review of Data Surveillance tools, systems and reports

• Work with team members to meet project goals and encourage the support of team members where required.
• Update all appropriate systems as indicated per function on an ongoing basis.
• Perform regular reviews of study data in clinical systems to ensure timely and high quality data from sites.
• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
• Develop expertise to become a subject matter expert.

QualificationsKnowledge and Experience:

• 5 + years of relevant medical, statistical, clinical or data management work experience recommended.
• Experience of working within a DDM study, and/or participating in the Data Surveillance process highly recommended.

Education:

• Educated to a degree level (medical, biological science, pharmacy or other health related discipline necessary). Advanced degree preferred, including MD, PhD, MSc

Language Skills:

• Fluent English

Apply for this job: Data Surveillance Analyst

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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