Data Surveillance Analyst based in South Africa, Poland, Lithuania

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

This position is available in the following EMEA locations South Africa Lithuania Poland and we offer fully remote home-based working.

Picture Yourself At Parexel:

The Data Surveillance Analyst (DSA) is responsible for analyzing scientific and operational data to support the Data Surveillance process and reviewing project-specific Quality Tolerance Limits. They assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews. The DSA also attends internal and external Data Surveillance meetings where they present relevant findings to the project team.

What Youll Do At Parexel:

Data Surveillance Plan Development and Technology Configuration:

• Support cross-functional study team with expertise of Data Surveillance Process and supporting technologies.

• Support the development of a robust Data Surveillance Plan including Key Risk Indicators Quality Tolerance Limits.

• Configure and Maintain Data Surveillance technologies.

Data Surveillance Review:

• Review relevant data via the scoped technologies identifying findings related to trends outliers emerging risks and systemic issues.

• Document findings from Data Surveillance review.

• Provide feedback and work with Technology teams to identify potential solutions that match the business and technology strategy.

• Perform presentations explaining identified findings to internal cross-functional study team and client team.

• Apply working knowledge and judgment to identify and evaluate potential data quality trend outliers and emergent issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided if applicable.

• Actively participate in external or internal meetings and audits & regulatory inspections as required.

• Recognize impact of studynon-compliance/issues/delays/dataquality signals and communicate/promptly escalate to FL any site and/or study issues that require immediate action.

• 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.

• Collaborate with DS Team Members to correlate findings from various sources.

• Support Project Leads with DS Review meeting driving reviews and decisions as needed and agreeing on actions.

• Engage DS Team to compile signals/actions into client ready list.

• Complete share and file Central Monitoring Report.

• Support Data Surveillance close out activities.

Here are a few requirements specific to this advertised role:

• Educated to a degree level (medical biological science pharmacy and/or data analytics preferred).

• Fluent English spoken & written.

• Min. 3 years of relevant medical clinical or data management work experience within CRO/Pharma.

• Experience of working within an adaptive monitoring design study and/or participating in a Central Monitoring/Data Surveillance process.

• Basic SAS programing or SQL or other programming languages with data analytics experience required.

• Familiarity with centralized monitoring and Data Driven Monitoring practices.

• Proficient in data analysis trend identification and issue triage.

• Risks management and control quality management and assurance experience.

• Client-focused with strong quality orientation.

• Excellent interpersonal and communication skills including presentation skills.

• Strong time management and multitasking capabilities.

• Ability to work independently with minimal supervision.

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial packages training and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.