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Data Surveillance Analyst

Job ID 64545BR United Kingdom - Any Region - Home Based
The role will be part of 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:
  • Support the development of a robust Data Surveillance Plan, Quality Tolerance Limits and Data Surveillance technologies (Parexel Data Surveillance, CluePoints Statistical Analysis Platform, etc.)
  • CluePoints:
    • Create data import mapping for all data sources within CluePoints.
    • Create and set-up standard and bespoke KRIs.
    • Create and set-up Data Quality Assessment parameters.
    • Create KRI and DQA dashboard.
    • 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 via the Data Surveillance application, CluePoints, 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.
  • Apply working knowledge and judgment to identify and evaluate potential data quality issues.
  • Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
  • Recognize impact of study non-compliance/issues/delays/data quality signals and communicate/ promptly escalate to FL any site and/or study issues that require immediate action.
  • CluePoints:
    • Refresh KRI and DQA data for each review cycle per DS Plan.
    • Perform core reviews of KRIs and all DQA domains.
    • Create signals of atypical data per DS Plan.
    • Collaborate with XFUNC leads to correlate CluePoints findings with XFUNC lead review findings from CluePoints and other sources.
    • Support PL with DS Review meeting, driving reviews and decisions as needed and agreeing actions
    • Triage signals/actions into client ready list.
    • Support documentation of actions in CluePoints Issue Management system (links to IH for any on-site interventions required).
  • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel/ Sponsor training requirements and study specific procedures, plans and training.
  • Perform regular reviews of study data in clinical systems to ensure timely and high-quality data from sites.
  • Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

Qualifications

Skills:
  • Client-centric, quality focused approach to work.
  • Ability to work in a matrix environment and contribute to the overall goals within project teams.
  • Ability to successfully work in a ‘virtual’ global team environment, encompassing different cultures.
  • Interpersonal skills that include the ability to communicate effectively within cross-functional project teams, ability to motivate others, delegation skills, drive to bring issues to resolution and timely/quality decision making.
  • Excellent verbal and written communication skills, as well as experience in presenting at internal and sponsor meetings, conveying complex data and information in a clear, concise manner.
  • Ability for effective time management in order to meet daily metrics, team objectives, and department goals.
  • Demonstrated ability to successfully manage a diverse number of tasks across multiple projects.
  • Comprehensive knowledge of PAREXEL RBM processes.
  • Understanding of statistical, analytical methods used to conduct centralized monitoring/data surveillance.
  • Demonstrated ability to review, analyze, interpret and identify trends/outliers within large volumes of complex scientific or operational data and triage identified issues appropriately.
  • Demonstrate basic understanding of SDTM domains and knowledge of data operations concepts.
  • Demonstrate basic SAS programming skills.
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • Demonstrated working knowledge and practical application of functionality of Parexel and vendor technologies supporting centralized monitoring/data surveillance and Data Driven Monitoring.
Knowledge and Experience:
  • 5 or more years of relevant medical, clinical or data management work experience recommended.
  • Experience of working within a DDM study, and/or participating in the Data Surveillance process highly recommended.
  • Basic SAS programming and/or SQL script writing.

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.

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