Data Surveillance Analyst - based in South Africa, Poland, Lithuania at Parexel

Bloemfontein, Free State, South Africa -

Full Time

Start Date

Immediate

Expiry Date

28 Sep, 26

Salary

0.0

Posted On

30 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Surveillance, Data Analysis, SAS Programming, SQL, Centralized Monitoring, Risk Management, Quality Management, Trend Identification, Issue Triage, ICH-GCP Guidelines, Clinical Data Management, Presentation Skills

Industry

Pharmaceutical Manufacturing

Description

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. 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 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. 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The Data Surveillance Analyst analyzes scientific and operational data to support the Data Surveillance process and reviews Quality Tolerance Limits. They develop Data Surveillance Plans and present findings on trends and risks to internal and external project teams.