Job Description

The Senior Data Surveillance Analyst (Sr DSA) drives all aspects of Data Surveillance, from plan development to final review. This position manages the implementation of support technologies and conducts analysis of scientific and operational data, including review of project-specific Quality Tolerance Limits. The Sr DSA participates in Data Surveillance Plan develop meetings, performs defined project reviews, and leads internal and external Data Surveillance review meetings. Additionally, the Sr DSA mentors junior team members, provides on-the-job training, and shares best practices with colleagues and project teams. The role requires a strong background in life sciences, understanding of GCP, and proficiency in statistical and analytical skills to interpret risk both qualitatively and quantitatively. This expertise enables the Sr DSA to strategically support Data Surveillance activities across the organization.

Key Accountabilities

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RBQM/ Department Support

Participate in cross functional initiatives/meetings Drive Department initiatives Metrics reporting

Business Development/Sponsor Support

BDM support Data Surveillance Process Presentations DS technologies demonstrations DS Findings / CluePoints Analysis Presentations

Data Surveillance Analysis Expert

Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits, and central statistical analysis Configure and Maintain Data Surveillance technologies (e.g., CluePoints Central Monitoring Platform) + Create data import mapping for all data sources.
+ Create and set-up standard and bespoke KRIs.
+ Create and set-up statistical analysis parameters.

Data Surveillance Reviews

Review relevant data via the scoped technologies and additional sources as required to support reviews designated for the DS Analyst per the project specific Data Surveillance Plan, including project specific Quality Tolerance Limits. Document findings from Data Surveillance activities in the DS Findings Form, Issue Tracking system(s) and other as appropriate. Review relevant country level information in via the scoped technologies, and/or other relevant reports, systems and listings, per the project specific Data Surveillance Plan. Provide COL with results of Operational Data reviews as per DS Plan. Participate in regular Data Surveillance meetings and communicate findings from various reviews to cross-functional leads on the project. Provide feedback on systems in use and work with Technology teams to identify potential solutions that match the business and technology strategy. Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable. Actively participate in Investigator and other 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 positive, results orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the HPC values. Work with team members to meet project goals and encourage the support of team members where required. Maintain a working knowledge of and ensure compliance with applicable ICHGCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study. Show commitment and perform consistent high-quality work. Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery. Provide input and feedback, as requested, for Performance Development Conversation(s). Complete routine departmental administrative tasks in a timely manner (e.g. timesheets, expenses, metrics). Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity). Develop expertise to become a subject matter expert. Refresh technologies for each review cycle per DS Plan. Perform core reviews per DS Plan. Document instances of atypical data per DS Plan. Collaborate with DS Team Members to correlate findings from various sources. Support PL 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 CluePoints Issue Management system (links to VV for any on-site interventions required). Complete, share, and file Central Monitoring Report. All other duties as assigned by management.

Skills:

Comprehensive knowledge of GCP, Parexel processes, and relevant technologies Understanding of statistical methods for Data Surveillance Strong analytical skills to identify trends in complex scientific and operational data Proficiency with Parexel technologies Strong critical thinking and problem-solving skills Basic knowledge of SDTM domains and Data Operations concepts Basic SAS programming skills Excellent interpersonal and communication skills, including presentation abilities Ability to triage and escalate quality issues per SOPs Effective multitasking across multiple projects Client-focused approach with ability to collaborate directly with sponsors Adaptability to work in a matrix and virtual team environment Time management skills to meet deadlines and objectives Cultural sensitivity and ability to work across diverse teams Ability to work independently while seeking guidance when needed Commitment to high-quality work and attention to detail Proficiency in CTMS, EDMS, and MS Office applications Flexibility and willingness to learn

Knowledge and Experience

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5 or more years of relevant medical, clinical or data management work experience recommended Experience of working within the Data Surveillance process required. Basic SAS programming

Education:

Educated to a degree level (medical, biological science, pharmacy and/or data analytics, preferred) or relevant clinical, technology or business equivalent * Advanced degree preferred, including MD, PhD, MSc