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Job Details

Data Surveillance Analyst

Company: PAREXEL
Location: Lithuania
Reference: 48963BR
Closing Date: 09 Jan 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

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:

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.
• Work with Technology teams to identify potential solutions that match the business and technology strategy.
• Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.
• 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 reportsQualificationsSkills:

• Demonstrated ability to review, analyze and understand and identify trends/outliers within large volumes of complex scientific or operational data.Understanding of statistical, analytical methods used to conduct Data Surveillance.
• Demonstrate basic understanding of SDTM domains and knowledge of Data Operations concepts.
• Interpersonal skills that include the ability to build effectively within cross-functional project teams, ability to motivate others, delegation skills, drive to bring issues to resolution and timely/quality decision making.
• Ability to triage quality issues and escalate serious quality findings or misconduct as per current SOPs.
• Demonstrated understanding and experience with current PAREXEL Informatics technology.
• Demonstrated ability to successfully manage a full workload diverse number of tasks across multiple-projects.
• Excellent verbal and written communication skills (including experience in making presentations at meetings, and conveying complex data and topics).
• Ability to work directly with sponsors (as required) as part of the Data Surveillance Team.
• Client focused approach to work.
• Ability to work in a matrix environment and contribute to the overall goals of HPC within project teams.
• Comprehensive knowledge of relevant technology and PAREXEL processes
• Excellent analytical and problem-solving skills
• Client focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Attention to detail.

Qualifications: Knowledge and Experience:

• 5 or more 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 preferred) or relevant clinical, technology or business equivalent. Advanced degree preferred, including MD, PhD, MScSkills:

• Demonstrated ability to review, analyze and understand and identify trends/outliers within large volumes of complex scientific or operational data.Understanding of statistical, analytical methods used to conduct Data Surveillance.
• Demonstrate basic understanding of SDTM domains and knowledge of Data Operations concepts.
• Interpersonal skills that include the ability to build effectively within cross-functional project teams, ability to motivate others, delegation skills, drive to bring issues to resolution and timely/quality decision making.
• Ability to triage quality issues and escalate serious quality findings or misconduct as per current SOPs.
• Demonstrated understanding and experience with current PAREXEL Informatics technology.
• Demonstrated ability to successfully manage a full workload diverse number of tasks across multiple-projects.
• Excellent verbal and written communication skills (including experience in making presentations at meetings, and conveying complex data and topics).
• Ability to work directly with sponsors (as required) as part of the Data Surveillance Team.
• Client focused approach to work.
• Ability to work in a matrix environment and contribute to the overall goals of HPC within project teams.
• Comprehensive knowledge of relevant technology and PAREXEL processes
• Excellent analytical and problem-solving skills
• Client focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Attention to detail.

Qualifications: Knowledge and Experience:

• 5 or more 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 preferred) or relevant clinical, technology or business equivalent. Advanced degree preferred, including MD, PhD, MSc

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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