Bloemfontein, Free State, South Africa · Remote OK
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 de…
Skills: Data Surveillance, Data Analysis, SAS Programming, SQL, Centralized Monitoring
Beijing, Beijing, China · On-site
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 de…
Skills: Clinical Writing, Medical Editing, Project Management, Regulatory Documentation, Quality Control
Illinois, United States · Remote OK
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 de…
Skills: Clinical Trial Monitoring, ICH/GCP, Site Management, FDA Regulations, Oncology
Dublin, Leinster, Ireland · Hybrid
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 de…
Skills: Contract Administration, Drafting Confidentiality Agreements, Database Management, Microsoft Office Suite, Excel
Maryland, United States · Remote OK
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 de…
Skills: Clinical Regulatory Affairs, Clinical Trial Design, Drug Development, Regulatory Strategy, Health Authority Interaction
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Clinical Data Management, Project Leadership, Cross-functional Collaboration, Risk Mitigation, Quality Management
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Oncology Monitoring, Site Management, GCP/ICH Compliance, Clinical Trial Monitoring, Regulatory Documentation
Tokyo, Japan · On-site
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 de…
Skills: Time Management, Multi-tasking, Communication Skills, Flexible Mindset, Clinical Trial Operations
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Site Management, Clinical Monitoring, ICH-GCP, Oncology, Regulatory Documentation
Bengaluru, Karnataka, India · Remote OK
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 de…
Skills: MS Office, Analytical Ability, Technical Communication, Systematic Literature Review, Data Extraction
Shanghai, Shanghai, China · On-site
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 de…
Skills: CTMS, EDMS, MS Office, ICH-GCP Guidelines, Trial Master File Management
Bloemfontein, Free State, South Africa · Remote OK
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 de…
Skills: SQL, SAS, R, Clinical Data Engineering, Data Ingestion
Bloemfontein, Free State, South Africa · On-site
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 de…
Skills: SQL, SAS, R, Clinical Data Engineering, Data Aggregation
New Jersey, United States · On-site
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 de…
Skills: HPLC/UHPLC/MS, Organic Chemistry, Materials Characterization, Chemical Process Development, Wet Chemistry
Serbia · Remote Solely
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 de…
Skills: Site Startup, Regulatory Compliance, Clinical Trial Methodology, CTMS, eTMF
Raleigh, North Carolina, United States · Hybrid
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 de…
Skills: Contract Drafting, Contract Negotiation, Legal Advice, Commercial Operations, Risk Management
Berlin, Germany · Remote OK
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 de…
Skills: Medical Monitoring, Clinical Trial Design, Medical Oversight, Protocol Preparation, Risk-Based Quality Management
Berlin, Germany · On-site
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 de…
Skills: Programming, Data Analysis, Clinical Trial Operations, Quality Assurance, Project Tracking
Osaka, Japan · Remote OK
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 de…
Skills: Medical Writing, Clinical Research, ICH-GCP, DSUR Preparation, Protocol Writing
Southport, North Carolina, United States · Remote OK
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 de…
Skills: Organizational Change Management, Stakeholder Engagement, Strategic Communications, Change Impact Analysis, Readiness Assessments
Bloemfontein, Free State, South Africa • Remote OK
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The Data Surveillance Analyst analyzes scientific and operational data to identify trends, outliers, and risks while developing Data Surveillance Plans. They are responsible for configuring surveillance technologies and presenting findings to cross-functional study and client teams.
Requires a degree in medical, biological science, pharmacy, or data analytics and at least 3 years of relevant experience in CRO/Pharma. Proficiency in SAS, SQL, or other data analytics programming languages is required.
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.
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.
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.
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.
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 22,000+ global employees 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.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
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 22,000+ global employees 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.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
