Senior Clinical Data Manager

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

📋 Description

• Act as a support-level member of a Clinical Data Management team.

• Assist in the design, specifications, and development of electronic Case Report Forms (eCRFs) following company standards.

• Coordinate the development and testing of clinical data management systems, including edit checks and listings/reports/tools.

• Aid in data review and discrepancy management processes.

• Contribute to the creation of Data Management Plan documents.

• Collaborate with external data vendors on data import and reconciliation tasks.

• Review all data produced from clinical trials, including third-party/external data, serious adverse event (SAE) data, and local lab data as applicable.

• Supervise quality control processes.

• Build and sustain communication and working relationships with the CDM team.

• Manage project timelines and ensure quality standards are met.

• Deliver reports, status updates, feedback, and recommendations to key study stakeholders regarding data cleaning and risk identification/mitigation.

• Ensure that CDM activities adhere to Good Clinical Practice and ICH Guidelines.

• Implement best practices and proactively suggest project solutions to the study team.

• Assist with the filing of electronic Trial Master Files (eTMF) documentation to maintain an inspection-ready state.

• Provide backup support for the Principal Clinical Data Lead as needed.

⛳️ Requirements

• Over 4 years of experience in Clinical Data Management.

• Ability to perform under pressure, showcasing agility through effective and innovative team leadership.

• Strong experience with Electronic Data Capture (EDC) systems, such as Medidata Rave.

• Familiarity with data review tools like Elluminate, J-Review, or Business Objects.

• Experience in Phase I/II clinical trials.

• Experience in neurology is preferred.

• Significant experience in study startup.

• Strong technical aptitude, particularly with Microsoft Excel functionalities.

• Proficient in English (both oral and written).

• Solid understanding of drug development and the biopharmaceutical sector.

• Exceptional attention to detail, with a proven capacity to manage multiple competing priorities.

• Excellent written and verbal communication skills.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.