Clinical Data Manager

About the Company:

Our client is an established, research-driven pharmaceutical company committed to improving the lives of patients with serious diseases. With a strong commercial presence in immunology and hematology and an exciting pipeline spanning additional therapeutic areas, the company combines scientific innovation with a patient-first mindset to develop therapies that address significant unmet medical needs.

The Opportunity:

As Clinical Data Manager, you will be responsible for the end-to-end management of clinical trial data across multiple global studies, ensuring the delivery of high-quality, reliable datasets that support regulatory submissions and clinical decision-making.

Working closely with Clinical Operations, Biostatistics, Medical, Regulatory Affairs and external CRO partners, you will oversee all aspects of clinical data management from study start-up through database lock across programmes.

Key Responsibilities:

• Lead all clinical data management activities for assigned Phase I-IV clinical studies.
• Develop and review Data Management Plans (DMPs), database specifications and study documentation.
• Coordinate database build, User Acceptance Testing (UAT), edit check development and validation activities.
• Manage external CROs and data management vendors to ensure delivery against agreed timelines, quality standards and budget.
• Review study data on an ongoing basis, identifying trends, discrepancies and data quality issues.
• Oversee data cleaning activities including query management and reconciliation processes.
• Coordinate external data transfers including laboratory, imaging, PK, biomarker and ePRO/eCOA data.
• Ensure compliance with CDISC standards where applicable, including SDTM requirements.
• Support database lock activities and ensure timely delivery of clean datasets.
• Collaborate with Biostatistics and Statistical Programming throughout data review and analysis.
• Participate in study team meetings, providing regular updates on data quality, timelines and risks.
• Ensure all activities comply with ICH-GCP, applicable regulatory requirements and company SOPs.
• Support inspections and audits by regulatory authorities where required.
• Contribute to continuous improvement initiatives, process optimisation and implementation of new technologies within Clinical Data Management.

Requirements:

• Bachelor's degree in Life Sciences, Computer Science, Biostatistics or a related discipline.
• 4+ years' Clinical Data Management experience within the pharmaceutical, biotechnology or CRO industry.
• Experience managing data across global interventional clinical trials.
• Strong understanding of ICH-GCP, FDA and EMA regulatory requirements.
• Experience working with Electronic Data Capture (EDC) systems such as Medidata Rave, Veeva CDMS, Oracle Inform or similar platforms.
• Knowledge of CDISC standards and clinical data quality principles.
• Experience managing external CROs and vendor relationships.
• Excellent organisational and project management skills.
• Strong communication skills with the ability to work effectively across cross-functional international teams.
• Fluent English (written and spoken).

Desirable