Senior Analytical Monitor
- High Wycombe, Buckinghamshire
- Permanent
- Full-time
- Conducting activities in compliance with J&J and functional SOPs, processes and policies.
- Supporting innovation or process improvement projects which may include but are not limited to requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.
- Facilitating smooth and effective communication, managing multiple communication streams and influencing key cross functional stakeholders. Following agreed escalation pathways where needed.
- Performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process for multiple trials, often of higher complexity.
- Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence
- Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level.
- Uses various systems, databases and reporting tools to identify potential risks related to site and subject level data quality, study participant safety, and compliance by identifying trends and early warning signals.
- Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement.
- Functional contacts in J&J Innovative Medicine include but are not limited to Site Managers and Local Trial Managers.
- Functional contacts within IDAR include but are not limited to Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
- External contacts include but are not limited to External Service Providers.
- Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences. Advanced degrees preferred (e.g., Masters, PhD).
- Minimum 8-12 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry!
- Knowledge of trial site operations and study execution
- Strong knowledge of regulatory guidelines (e.g., ICH-GCP).
- Demonstrated strong understanding of data analysis and familiarity with basic statistical concepts and hands-on experience using data visualization tools
- Project, Issue, and risk management experience with strong ability to apply critical thinking & problem-solving skills, to drive solutions &helping to lead teams to successful outcomes.
- Strong experience working with technology platforms and systems used for the collection, analysis and reporting of data.
- Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional
- Planning and coordination skills. Experience working with cross-functional stakeholders and leading teams in a matrix environment and partnering with/managing stakeholders.
- Strong leadership and communication skills (written and verbal). Ability to influence stakeholders.
- Excellent written and verbal communication skills (in English)
- Strong knowledge of clinical drug development processes
- Working with complex data structures and reporting specifications
- Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
- Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas.
- Strong Knowledge of Monitoring and Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts