Data Surveillance Analyst - based in South Africa
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference. Parexel is currently seeking a Data Surveillance Analyst to join us in South Africa. 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 You'll 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 study non-compliance/issues/delays/data quality 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. Knowledge of programing languages. Basic SAS programming and/or SQL script writing preferred. Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended. 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 preferred. Client-focused with strong quality orientation. Effective in matrix and global virtual team environments. 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.