Clinical Monitoring Analyst

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assist the Centralized Monitoring Lead in creating tailored centralized monitoring strategies.

• Aid in the identification of Quality Tolerance Limits, Key Risk Indicators, data visualizations, and Data Quality Assessments.

• Establish and program QTLs, KRIs, and Data Quality Assessments in accordance with the study's Centralized Monitoring Plan.

• Update the Centralized Monitoring Platform at designated intervals to facilitate signal detection.

• Create and uphold specifications for the Centralized Monitoring Platform and ensure they are properly filed in the eTMF.

• Review and comprehend study protocols thoroughly.

• Understand the sources of study data, transfer specifications, and data structures.

• Conduct and document peer reviews of platform setups performed by other CMA colleagues.

• Collaborate directly with the sponsor client to oversee project deliveries.

⛳️ Requirements

• Minimum of 3 years of relevant experience in pharmaceutical research and development or a related field, ideally in centralized monitoring, data management, and/or biostatistics.

• 2–3 years of experience with SAS, including the macro language.

• Familiarity with Cluepoints is preferred.

• Capability to work independently and engage effectively with relevant stakeholders.

• Understanding of basic statistical analysis concepts and the ability to interpret results.

• Commitment to maintaining the confidentiality of data and information.

• Ability to work with minimal supervision.

• Proven communication, interpersonal, organizational, and problem-solving abilities.

• High levels of initiative, drive, and dedication.

• Previous experience in a Data Management-related role.

• Experience with relational databases, preferably in Clinical Data Management and EDC systems.

• Proven experience in communicating with personnel at all levels and collaborating within diverse work teams, both locally and globally.

• Advanced understanding of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.

• Excellent verbal and written proficiency in English.

• This position is not eligible for UK visa sponsorship.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunity for professional development and training.

• Flexible working hours and remote work options.

• Collaborative and inclusive work environment.

• Competitive salary and performance-based incentives.