Data Surveillance Analyst, POLAND at Parexel

, , Poland -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

0.0

Posted On

09 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Surveillance, Data Analysis, Trend Identification, Issue Triage, SAS Programming, SQL Scripting, CluePoints System, Quality Management, Risk Management, Communication Skills, Interpersonal Skills, Time Management, Multitasking, Client Focus, Empathy, Regulatory Compliance

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. Parexel is currently seeking a Data Surveillance Analyst to join us in Poland. 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 (e.g., Clue Points Central Monitoring Platform). 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. Support documentation of actions in Clue Points Issue Management system. Complete, share, and file Central Monitoring Report. Support Data Surveillance close out activities. Here are a few requirements specific to this advertised role: Min. 2 to 3 years of relevant medical, clinical or data management work experience. Experience of working within an adaptive monitoring design study, and/or participating in a Central Monitoring/Data Surveillance process highly recommended. Basic SAS programming and/or SQL script writing required. Experience with CluePoints system required. Educated to a degree level (medical, biological science, pharmacy, and/or data analytics, preferred) Fluent English – spoken & written Familiarity with centralized monitoring and Data Driven Monitoring practices. Proficient in data analysis, trend identification, and issue triage. Knowledge of programing languages highly recommended. 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 abilities. 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 has a fully flexible work arrangement - you can be fully home based. But if you live close to our office and you want to use it, you are always welcome, and we will keep the desk ready for you! Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Responsibilities

The Data Surveillance Analyst 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 and conduct defined project reviews, presenting findings to the project team.